Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
RECIDREAM
Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
1 other identifier
interventional
216
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2025
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2023
CompletedFirst Posted
Study publicly available on registry
April 28, 2023
CompletedStudy Start
First participant enrolled
April 8, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 8, 2028
November 21, 2025
November 1, 2025
3 years
April 19, 2023
November 18, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (10)
Sleep efficiency calculated by actimetry and expressed in percentage.
12 months after baseline
Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)
12 months after baseline
total sleep time
12 months after baseline
sleep onset latency
12 months after baseline
intra-sleep wake duration
12 months after baseline
- +5 more secondary outcomes
Study Arms (1)
Sleep activity
EXPERIMENTALActigraphy : 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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:
- clinical remission: Harvey-Bradshaw score (HBI) \< 5 for CD and a Mayo score \< 3 for UC
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, 63100, France
CHU Grenoble Hôpital Michallon-Site Nord
Grenoble, 38700, France
Lyon Sud hospital
Pierre-Bénite, 69310, France
CHU Saint Etienne
Saint-Etienne, 42270, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 19, 2023
First Posted
April 28, 2023
Study Start
April 8, 2025
Primary Completion (Estimated)
April 8, 2028
Study Completion (Estimated)
June 8, 2028
Last Updated
November 21, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share