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NCT Number: NCT05835973

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

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.

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Key information

Conditions

Disease Bowel Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Disease Attributes Dyssomnias Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Signs and Symptoms Sleep Deprivation Sleep Wake Disorders Ulcerative Colitis

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Clermont-Ferrand, Hôpital d'Estaing, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Sleep activity

Other

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

Other

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 outcomes

  1. 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

  1. Sleep efficiency calculated by actimetry and expressed in percentage.

    Time frame: 12 months after baseline

    Patient will wear actimeters on the wrist for 1 year continuously.

  2. Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)

    Time frame: 12 months after baseline

    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.

  3. total sleep time

    Time frame: 12 months after baseline

    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).

  4. sleep onset latency

    Time frame: 12 months after baseline

    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).

  5. intra-sleep wake duration

    Time frame: 12 months after baseline

    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).

  6. polysomnographic sleep efficiency

    Time frame: 12 months after baseline

    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).

  7. quantity of different sleep stages

    Time frame: 12 months after baseline

    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).

  8. index of micro-arousals

    Time frame: 12 months after baseline

    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).

  9. spindle density

    Time frame: 12 months after baseline

    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).

  10. delta spectral power in slow wave sleep

    Time frame: 12 months after baseline

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Gilles Boschetti, MD,PhD

CONTACT

[email protected]

+33 4 78 86 13 02

Maelys Cheviakoff

CONTACT

[email protected]

+33 4 78 86 37 66

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: RECIDREAM

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 28, 2023
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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