CDE Detailed Report
Subdomain Name: Sleep
CRF: Sleep Focused Study Questionnaire
Displaying 1 - 19 of 19
| CDE ID | CDE Name | Variable Name | Definition | Short Description | Question Text | Permissible Values | Description | Data Type | Disease Specific Instructions | Disease Specific Reference | Population | Classification (e.g., Core) | Version Number | Version Date | CRF Name (CRF Module / Guidance) | Subdomain Name | Domain Name | Size | Input Restrictions | Min Value | Max Value | Measurement Type | External Id Loinc | External Id Snomed | External Id caDSR | External Id CDISC |
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| C57105 | Acclimation process description text | AccPrcssDscrptnTxt | Free text field related to the description of the acclimation process used | Free text field related to the description of the acclimation process used | If yes, describe the acclimation process and/or pre-study instructions. (free text) | Alphanumeric | 1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:09:50.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C58442 | Objective measure when performed text | ObjctMeasrWhenPerfromTxt | Text indicating when the objective measures were performed | Text indicating when the objective measures were performed | When measures were performed | Alphanumeric |
In a number of studies, ME/CFS study participants demonstrate lower heart rate variability (HRV) nocturnally compared to controls. Low heart rate variability may be linked to fatigue and unrefreshing sleep. More research to confirm and extend prior work is needed. HRV measures used in prior studies include HRV (heart rate variability), LF power (low-frequency power(ms?)), HF power (high-frequency power(ms?)), LF/HF ratio, TP (Total power(ms?)), RMSSD (root of the mean squares of differences between adjacent R–R intervals), SDNN (standard deviation on R–R intervals), COVR (coefficient of variation), PNN50 (number of pairs of adjacent R–R intervals differing by 450 ms divided by the total number of R–R intervals). Researchers should try to include one if not more of these measures when investigating HRV. HRV can be confounded by many factors and these should be taken into account when designing studies. Some factors that have been identified are age, gender, medication use, presence of a psychiatric condition, physical activity, breathing rate/ frequency, heart disease, and acute stress situations. The equipment used should have been validated against a gold standard like ECG. |
Adult;Pediatric | Supplemental | 1.00 | 2018-02-14 10:05:52.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C57106 | Medication help sleep problem indicator | MdHlpSlpPrbInd | Indicator of whether medication was taken regularly to help with sleep problems | Indicator of whether medication was taken regularly to help with sleep problems | Did the subject take any prescription/over the counter medication, supplements, or herbal preparations regularly to help with their sleep problems? | No;Yes | No;Yes | Alphanumeric | 1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:13:44.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C58443 | Objective measure describe equipment used text | ObjctMeasrDesEquipUseTxt | Text describing what objective measures equipment used | Text describing what objective measures equipment used | Describe equipment used | Alphanumeric |
In a number of studies, ME/CFS study participants demonstrate lower heart rate variability (HRV) nocturnally compared to controls. Low heart rate variability may be linked to fatigue and unrefreshing sleep. More research to confirm and extend prior work is needed. HRV measures used in prior studies include HRV (heart rate variability), LF power (low-frequency power(ms?)), HF power (high-frequency power(ms?)), LF/HF ratio, TP (Total power(ms?)), RMSSD (root of the mean squares of differences between adjacent R–R intervals), SDNN (standard deviation on R–R intervals), COVR (coefficient of variation), PNN50 (number of pairs of adjacent R–R intervals differing by 450 ms divided by the total number of R–R intervals). Researchers should try to include one if not more of these measures when investigating HRV. HRV can be confounded by many factors and these should be taken into account when designing studies. Some factors that have been identified are age, gender, medication use, presence of a psychiatric condition, physical activity, breathing rate/ frequency, heart disease, and acute stress situations. The equipment used should have been validated against a gold standard like ECG. |
Adult;Pediatric | Supplemental | 1.00 | 2018-02-14 10:07:50.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C57107 | Medication taken neurologic psychiatric affect sleep indicator | MdTknNrPsyAffSlpInd | Indicator of if the subject has taken any neurologic or psychiatric medication that is known to affect sleep | Indicator of if the subject has taken any neurologic or psychiatric medication that is known to affect sleep | Did the subject take any neurologic, psychiatric medications, or other medication commonly known to affect sleep? | No;Yes | No;Yes | Alphanumeric |
List medicines vs. specify drug categories in the medication log. |
1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:26:26.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C57108 | Medication neurologic psychiatric type text | MdNrlPsycTypTxt | Free text field of medication (neurologic or psychiatric) type that was taken that is known to affect sleep | Free text field of medication (neurologic or psychiatric) type that was taken that is known to affect sleep | If yes, what medications did the subject take? (List medicines vs. specify drug categories) | Alphanumeric |
List of medicines if the subject has taken any neurologic, psychiatric medications or other mediation commonly known to affect sleep. |
1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:32:08.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C57109 | Medication affect sleep stop indicator | MdAffctSlpStpInd | Indicator of whether medications known to affect sleep were stopped before the sleep study | Indicator of whether medications known to affect sleep were stopped before the sleep study | Were all medications that could affect sleep stopped before the sleep study? | Other instructions given, please specify;No specific instructions given to subject;Yes;No | Other instructions given, please specify;No specific instructions given to subject;Yes;No | Alphanumeric | 1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:57:19.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C17402 | Site name | SiteName | The name of the site for the study | The name of the site for the study | Site Name | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 3.00 | 2013-06-21 00:00:00.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C57110 | Sleep wake time correspond subject sleep wake time indicator | SlpWkTmeCrrsSbjctSlpWkTmInd | Indicator of whether sleep/wake times correspond to the subjects' usual sleep/wake times | Indicator of whether sleep/wake times correspond to the subjects' usual sleep/wake times | Did sleep/wake times correspond to the subjects' usual sleep/wake times? | No;Yes | No;Yes | Alphanumeric |
Note: In prior sleep studies, subjects slept or woke up based on researcher-determined times, which might be very different from what the subject's usual sleep/wake schedules. If sleep and wake times in a study are very different from a study participant's usual schedule, these factors can impact results |
1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 17:19:40.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C19247 | Subject ID | SubIDNam | Subject identification ID | Subject identification ID | Subject ID | Alphanumeric | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2014-06-05 13:10:49.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C57111 | Objective measure heart rate variability indicator | ObjctvMeasrHrtRtVrbltyInd | Indicator of whether objective measures related to heart rate variability were employed | Indicator of whether objective measures related to heart rate variability were employed | Were objective measures related to heart rate variability employed | No;Yes | No;Yes | Alphanumeric |
Were objective measures related to heart rate variability employed? - In a number of studies, ME/CFS study participants demonstrate lower heart rate variability (HRV) nocturnally compared to controls. Low heart rate variability may be linked to fatigue and unrefreshing sleep. More research to confirm and extend prior work is needed. HRV measures used in prior studies include HRV (heart rate variability), LF power (low-frequency power(ms?)), HF power (high-frequency power(ms?)), LF/HF ratio, TP (Total power(ms?)), RMSSD (root of the mean squares of differences between adjacent R–R intervals), SDNN (standard deviation on R–R intervals), COVR (coefficient of variation), PNN50 (number of pairs of adjacent R–R intervals differing by 450 ms divided by the total number of R–R intervals). Researchers should try to include one if not more of these measures when investigating HRV. HRV can be confounded by many factors and these should be taken into account when designing studies. Some factors that have been identified are age, gender, medication use, presence of a psychiatric condition, physical activity, breathing rate/ frequency, heart disease, and acute stress situations. The equipment used should have been validated against a gold standard like ECG. |
1. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />2. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental | 1.00 | 2017-12-27 17:32:55.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C57101 | MECFS prior history sleep problem indicator | MECFSPrHstSlpPrbInd | Indicator of whether the subject had a history of sleep problems prior to MECFS | Indicator of whether the subject had a history of sleep problems prior to MECFS | Did the subject have a history of sleep problems prior to developing ME/CFS? | No;Yes | No;Yes | Alphanumeric |
Researchers will have to account for and / or separate out the effects of sleep disorders from the effects of ME/CFS on sleep study results |
1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 15:25:20.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C58438 | Prior to study medication stopped duration | PriorToStdyMedStopDur | Yes or other instructions given indicating the duration of time prior to the sleep study that that subject stopped medications that could affect sleep | Yes or other instructions given indicating the duration of time prior to the sleep study that that subject stopped medications that could affect sleep | If 'yes' or 'other instructions given', how long prior to the study were medications stopped? | Numeric Values |
Yes or other instructions given indicating how long prior to the sleep study subject stopped the medications that could affect sleep |
Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2018-02-14 09:24:56.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Free-Form Entry |
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| C57102 | Sleep problem diagnosis type | SlpPrbDiagTyp | Type of diagnosis for sleep problem | Type of diagnosis for sleep problem | If yes, what was the diagnosis? | Alphanumeric | 1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 15:52:17.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C58439 | Medication stopped other instructions given specify text | MedStopOthrInstrucGivSpecTxt | Other instructions given to subject indicating if medications that could affect sleep were stopped prior to sleep study | Other instructions given to subject indicating if medications that could affect sleep were stopped prior to sleep study | Other instructions given, please specify | Alphanumeric |
Specify if the subject was given other instructions regarding stopping medication that could affect sleep before the sleep study |
Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2018-02-14 09:37:48.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 500 |
Free-Form Entry |
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| C57103 | Issue present no diagnosis type | IssPrsntNoDiagTyp | Type of issues present without diagnosis | Type of issues present without diagnosis | If no diagnosis, what issues were present (i.e., sleep disturbance, early wakening, staying asleep, other specify) | Alphanumeric | 1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 15:54:47.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
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| C58440 | Objective measure taken what measure text | ObjMeasrTkenWhatMeasrTxt | Text indicating what objective measures were taken | Text indicating what objective measures were taken | What was measured | Alphanumeric |
In a number of studies, ME/CFS study participants demonstrate lower heart rate variability (HRV) nocturnally compared to controls. Low heart rate variability may be linked to fatigue and unrefreshing sleep. More research to confirm and extend prior work is needed. HRV measures used in prior studies include HRV (heart rate variability), LF power (low-frequency power(ms?)), HF power (high-frequency power(ms?)), LF/HF ratio, TP (Total power(ms?)), RMSSD (root of the mean squares of differences between adjacent R–R intervals), SDNN (standard deviation on R–R intervals), COVR (coefficient of variation), PNN50 (number of pairs of adjacent R–R intervals differing by 450 ms divided by the total number of R–R intervals). Researchers should try to include one if not more of these measures when investigating HRV. HRV can be confounded by many factors and these should be taken into account when designing studies. Some factors that have been identified are age, gender, medication use, presence of a psychiatric condition, physical activity, breathing rate/ frequency, heart disease, and acute stress situations. The equipment used should have been validated against a gold standard like ECG. |
Adult;Pediatric | Supplemental | 1.00 | 2018-02-14 10:00:56.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 500 |
Free-Form Entry |
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| C57104 | Acclimation period before study indicator | AcclmPrdBfrStdyInd | Indicator of whether there was an acclimation period (e.g. a night when subjects were set up for a polysomnography (PSG) but no official measurements (taken) or instructions given to subjects before the study began to individual subjects | Indicator of whether there was an acclimation period (e.g. a night when subjects were set up for a polysomnography (PSG) but no official measurements (taken) or instructions given to subjects before the study began to individual subjects | Was there an acclimation period (e.g. a night when subjects were set up for polysomnography (PSG) but no official measurements taken) or instructions given to subjects before the study began for individual subjects? | No;Yes | No;Yes | Alphanumeric |
Acclimation in this CRF is defined as a night when subjects were set up for PSG but no official measurements taken. Without an acclimation periods, results from PSG could be a reflection of study participants' adaptation to PSG rather than effects of the ME/CFS itself. Instructions given before a sleep study may also impact results. For example, some researchers have asked study participants to avoid caffeine for 24 hours pre-study. Use of prescription/ over-the-counter medications, herbal concoctions, and various supplements can affect sleep study results. Consequently it is important for researchers to communicate how these were accounted for in their studies. |
1. Jackson ML, Bruck D. Sleep Abnormalities in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: A Review. Journal of Clinical Sleep Medicine?: JCSM?: Official Publication of the American Academy of Sleep Medicine. 2012;8(6):719-728. doi:10.5664/jcsm.2276.<br /><br />2. Meeus M, Goubert D, De Backer F, Struyf F, Hermans L, Coppieters I, De Wandele I, Da Silva H, Calders P. Heart rate variability in patients with fibromyalgia and patients with chronic fatigue syndrome: a systematic review. Semin Arthritis Rheum. 2013 Oct;43(2):279-87. doi: 10.1016/j.semarthrit.2013.03.004. Epub 2013 Jul 6.<br /><br />3. Tak LM, Riese H, de Bock GH, Manoharan A, Kok IC, Rosmalen JG. As good as it gets? A meta-analysis and systematic review of methodological quality of heart rate variability studies in functional somatic disorders. Biol Psychol. 2009 Oct;82(2):101-10. doi: 10.1016/j.biopsycho.2009.05.002. Epub 2009 May 20. <br />a. This is an older article. It is being referenced because it contains a table designating elements that should be reported in studies of heart rate variability. | Adult;Pediatric | Supplemental-Highly Recommended | 1.00 | 2017-12-27 16:05:23.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points |
Single Pre-Defined Value Selected |
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| C58441 | Objective measure method of measurement text | ObjctMeasrMethOfMeasurmntTxt | Text indicating objective measures method of measurement | Text indicating objective measures method of measurement | Method of measurement | Alphanumeric |
In a number of studies, ME/CFS study participants demonstrate lower heart rate variability (HRV) nocturnally compared to controls. Low heart rate variability may be linked to fatigue and unrefreshing sleep. More research to confirm and extend prior work is needed. HRV measures used in prior studies include HRV (heart rate variability), LF power (low-frequency power(ms?)), HF power (high-frequency power(ms?)), LF/HF ratio, TP (Total power(ms?)), RMSSD (root of the mean squares of differences between adjacent R–R intervals), SDNN (standard deviation on R–R intervals), COVR (coefficient of variation), PNN50 (number of pairs of adjacent R–R intervals differing by 450 ms divided by the total number of R–R intervals). Researchers should try to include one if not more of these measures when investigating HRV. HRV can be confounded by many factors and these should be taken into account when designing studies. Some factors that have been identified are age, gender, medication use, presence of a psychiatric condition, physical activity, breathing rate/ frequency, heart disease, and acute stress situations. The equipment used should have been validated against a gold standard like ECG. |
Adult;Pediatric | Supplemental | 1.00 | 2018-02-14 10:03:57.0 | Sleep Focused Study Questionnaire | Sleep | Outcomes and End Points | 255 |
Free-Form Entry |
