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).

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 Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease; Ulcerative Colitis; Disease Bowel
• Intervention / Treatment: Other: Sleep activity; Other: Questionnaires

• Study Type: Interventional
• Enrollment (Estimated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gilles Boschetti, MD,PhD; Phone Number: +33 4 78 86 13 02; Email: gilles.boschetti@chu-lyon.fr
• Study Contact Backup: Name: Maelys Cheviakoff; Phone Number: +33 4 78 86 37 66; Email: maelys.cheviakoff01@chu-lyon.fr

Study Locations

• France
  • Clermont-Ferrand, France, 63100
    • CHU Clermont-Ferrand, Hôpital d'Estaing
    • Contact: Anthony BUISSON
  • Grenoble, France, 38700
    • CHU Grenoble Hôpital Michallon-Site Nord
    • Contact: Nicolas MATHIEU
  • Pierre-Bénite, France, 69310
    • Lyon Sud Hospital
    • Contact: Gilles BOSCHETTi, MD,PhD
  • Saint Etienne, France, 42270
    • Chu Saint Etienne
    • Contact: Xavier Roblin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.; Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep efficiency calculated by actimetry and expressed in percentage.	Patient will wear actimeters on the wrist for 1 year continuously.	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.	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).	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).	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).	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).	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).	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).	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).	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).	12 months after baseline

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: April 19, 2023
• First Posted (Actual): April 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: relapse; Crohn's disease; ulcerative colitis; Inflammatory Bowel Diseases; sleep deprivation
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Inflammatory Bowel Diseases; Crohn Disease; Intestinal Diseases; Colitis; Colitis, Ulcerative
• Other Study ID Numbers: 69HCL22_0907

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No