An interventional study of Sleep activity and Questionnaires in Disease Bowel, Crohn Disease and Ulcerative Colitis, sponsored by Hospices Civils de Lyon. Recruiting at 4 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-11-21.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Other
Inflammatory Bowel Diseases (IBD) go through two phases: flare and remission. Prediction of flares and identification of patients in remission but at high risk of flare are a major issue when taking care of IBD patients.
Considering close interactions between sleep, immunity and intestinal inflammation, sleep disorders could be a predictor of flares.
The purpose of this study is to demonstrate that sleep efficacy decreases before IBD flare.
Patients in remission will be assessed for IBD symptoms (activity scores, biological factors) and sleep disorders (actigraphy, DREEM®, questionnaires) during one year.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's planned enrollment of 216 is above the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Hospices Civils de Lyon is the lead sponsor of 1,826 studies on the registry; 439 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patient in remission, for at least 3 months:
Exclusion Criteria:
Actigraphy : Patient will wear actinometers on the wrist for 1 year continuously. In the study, MotionWatch 8 actimeters will be used, a class 1 medical device with CE mark (EN ISO 13485:2016 standard). They will be provided by the company camntech. Ancillary Study: DREEM 3 headband : a subgroup of patients will wear the headband during 2 nights every 3 months.
Other: Sleep activity · Other: Questionnaires
Actinography : Patient will wear actinometers on the wrist for 1 year continuously. In the study, MotionWatch 8 actimeters will be used, a class 1 medical device with CE mark (EN ISO 13485:2016 standard). Ancillary study : DREEM 3 headband : a subgroup of patients will wear the headband during 2 nights every 3 months.
The PSQI, EPWORTH, FACIT-F, ISI, and ICSD-3 questionnaires will be completed by patients every 3 months during their follow-up consultation according to the usual management. The questionnaire by Horne and Ostberg will be completed by the patients only during the inclusion visit.
rate of relapse
For Crohn's disease: Harvey Bradshaw Index ≥ 5 AND a CRP \> 5 mg/L and/or calprotectin \> 250 µg/g For ulcerative colitis: Mayo ≥ 3 AND a CRP \> 5 mg/L and/or calprotectin \> 250 µg/g Sleep efficiency will be measured by actimetry and expressed as a percentage. Sleep efficiency is defined as the ratio of total time spent asleep compared to total time spent in bed. An actinometer will collect one efficiency measurement per night; an average per week will then be calculated from the daily measurements.
Time frame: 12 months after baseline
Sleep efficiency calculated by actimetry and expressed in percentage.
Patient will wear actimeters on the wrist for 1 year continuously.
Time frame: 12 months after baseline
Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)
Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min) will be measured with an actinometer, and averaged per week. Patient will wear actinometers on the wrist for 1 year continuously.
Time frame: 12 months after baseline
total sleep time
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
sleep onset latency
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
intra-sleep wake duration
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
polysomnographic sleep efficiency
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
quantity of different sleep stages
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
index of micro-arousals
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
spindle density
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
delta spectral power in slow wave sleep
Sleep parameters evaluated by headband are: * sleep macrostructure: concerns the polycyclic organization of sleep and the following quantitative parameters: total sleep time (min), sleep onset latency (min), intra-sleep wake duration (min), polysomnographic sleep efficiency (= total sleep time/time in bed), quantity of different sleep stages (min and % of total sleep time) * sleep microstructure: concerns the index of micro-arousals (number/hour) and spindle density (number/minute) or delta spectral power in slow wave sleep (delta/total power ratio).
Time frame: 12 months after baseline
Plan to share: No
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Hospices Civils de Lyon