Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.

Ulcerative Colitis Clinical Trial

— RECIDREAM  

Official title:

Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05835973
• Other study ID #: 69HCL22_0907
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: September 1, 2026

Study information

• Verified date: March 2024
• Source: Hospices Civils de Lyon
• Contact: Gilles Boschetti, MD,PhD
• Phone: +33 4 78 86 13 02
• Email: gilles.boschetti[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient over 18 and under 65 years of age.
• Patient with Inflammatory Bowel Disease diagnosed for at least 3 months.
• Patient in remission, for at least 3 months:

1. clinical remission: Harvey-Bradshaw score (HBI) < 5 for CD and a Mayo score < 3 for UC

2. and biological remission: absence of objective inflammation defined by CRP < 5 mg/L and/or fecal calprotectin < 250 µg/g.

• Patient must sign informed consent form to participate to the study.
• Patient affiliated to or benefiting from a social security plan.

Exclusion Criteria:

• Patient with complications (obstructive symptoms, fistulas or intra-abdominal abscesses in the previous three months).
• Patient with extensive bowel resection (> 40 cm of small bowel).
• Patient with an ileostomy or colostomy.
• Patient diagnosed with sleep disorders.
• Patient without legal capacity to consent.
• Pregnant, parturient or nursing women.
• Persons deprived of liberty by judicial or administrative decision.
• Persons under psychiatric care.
• Persons admitted to a health or social institution for purposes other than research.
• Persons of full age who are subject to a legal protection measure (guardianship, curators).

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Ulcerative Colitis

Intervention

Other:
• Sleep activity
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.
• Questionnaires
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.

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand, Hôpital d'Estaing	Clermont-Ferrand
France	CHU Grenoble Hôpital Michallon-Site Nord	Grenoble
France	Lyon Sud hospital	Pierre-Bénite
France	CHU Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months after baseline
Secondary	Sleep efficiency calculated by actimetry and expressed in percentage.	Patient will wear actimeters on the wrist for 1 year continuously.	12 months after baseline
Secondary	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.	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline
Secondary	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).	12 months after baseline