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Recruiting NCT05835973

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

No phase Interventional Disease Bowel Crohn Disease Ulcerative Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sleep activity, Questionnaires.
Who it may be relevant to
Registry conditions: Disease Bowel, Crohn Disease, Ulcerative Colitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • rate of relapse [Time frame: 12 months after baseline]
Secondary outcome measures (10)
  • Sleep efficiency calculated by actimetry and expressed in percentage. [Time frame: 12 months after baseline]
  • Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min) [Time frame: 12 months after baseline]
  • total sleep time [Time frame: 12 months after baseline]
  • sleep onset latency [Time frame: 12 months after baseline]
  • intra-sleep wake duration [Time frame: 12 months after baseline]
  • polysomnographic sleep efficiency [Time frame: 12 months after baseline]
  • quantity of different sleep stages [Time frame: 12 months after baseline]
  • index of micro-arousals [Time frame: 12 months after baseline]
  • spindle density [Time frame: 12 months after baseline]
  • delta spectral power in slow wave sleep [Time frame: 12 months after baseline]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 4 centers
  • CHU Clermont-Ferrand, Hôpital d'Estaing — Clermont-Ferrand
  • CHU Grenoble Hôpital Michallon-Site Nord — Grenoble
  • Lyon Sud hospital — Pierre-Bénite
  • CHU Saint Etienne — Saint-Etienne

Identifiers

NCT: NCT05835973 · 69HCL22_0907

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗