Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 216
- Locations
- 5
- Primary Endpoint
- rate of relapse
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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:
- •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.
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).
Arms & Interventions
Sleep activity
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.
Intervention: Sleep activity (Other)
Sleep activity
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.
Intervention: Questionnaires (Other)
Outcomes
Primary Outcomes
rate of relapse
Time Frame: 12 months after baseline
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.
Secondary Outcomes
- intra-sleep wake duration(12 months after baseline)
- polysomnographic sleep efficiency(12 months after baseline)
- Sleep efficiency calculated by actimetry and expressed in percentage.(12 months after baseline)
- sleep onset latency(12 months after baseline)
- Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)(12 months after baseline)
- index of micro-arousals(12 months after baseline)
- total sleep time(12 months after baseline)
- delta spectral power in slow wave sleep(12 months after baseline)
- quantity of different sleep stages(12 months after baseline)
- spindle density(12 months after baseline)