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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05835973

Collaborator

(none)

216

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Disease Bowel Crohn Disease Ulcerative Colitis	Other: Sleep activity Other: Questionnaires	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

216 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2026

Anticipated Study Completion Date :

Sep 1, 2026

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

rate of relapse [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 Outcome Measures

Sleep efficiency calculated by actimetry and expressed in percentage. [12 months after baseline]
Patient will wear actimeters on the wrist for 1 year continuously.
Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min) [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.
total sleep time [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).
sleep onset latency [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).
intra-sleep wake duration [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).
polysomnographic sleep efficiency [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).
quantity of different sleep stages [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).
index of micro-arousals [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).
spindle density [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).
delta spectral power in slow wave sleep [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CHU Clermont-Ferrand, Hôpital d'Estaing	Clermont-Ferrand	France	63100
2	CHU Grenoble Hôpital Michallon-Site Nord	Grenoble	France	38700
3	Lyon Sud hospital	Pierre-Bénite	France	69310
4	CHU Saint Etienne	Saint Etienne	France	42270