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

Primary Purpose

Disease Bowel, Crohn Disease, Ulcerative Colitis

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sleep activity
Questionnaires
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Disease Bowel focused on measuring Inflammatory Bowel Diseases, Crohn's disease, ulcerative colitis, sleep deprivation, relapse

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

  • CHU Clermont-Ferrand, Hôpital d'Estaing
  • CHU Grenoble Hôpital Michallon-Site Nord
  • Lyon Sud hospital
  • CHU Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sleep activity

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Sleep efficiency calculated by actimetry and expressed in percentage.
Patient will wear actimeters on the wrist for 1 year continuously.
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.
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).
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).
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).
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).
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).
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).
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).
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).

Full Information

First Posted
April 19, 2023
Last Updated
August 11, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05835973
Brief Title
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
Acronym
RECIDREAM
Official Title
Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
September 1, 2026 (Anticipated)
Study Completion Date
September 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease Bowel, Crohn Disease, Ulcerative Colitis
Keywords
Inflammatory Bowel Diseases, Crohn's disease, ulcerative colitis, sleep deprivation, relapse

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep activity
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Sleep activity
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Questionnaires
Intervention Description
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 Measure Information:
Title
rate of relapse
Description
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.
Time Frame
12 months after baseline
Secondary Outcome Measure Information:
Title
Sleep efficiency calculated by actimetry and expressed in percentage.
Description
Patient will wear actimeters on the wrist for 1 year continuously.
Time Frame
12 months after baseline
Title
Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min)
Description
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.
Time Frame
12 months after baseline
Title
total sleep time
Description
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).
Time Frame
12 months after baseline
Title
sleep onset latency
Description
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).
Time Frame
12 months after baseline
Title
intra-sleep wake duration
Description
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).
Time Frame
12 months after baseline
Title
polysomnographic sleep efficiency
Description
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).
Time Frame
12 months after baseline
Title
quantity of different sleep stages
Description
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).
Time Frame
12 months after baseline
Title
index of micro-arousals
Description
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).
Time Frame
12 months after baseline
Title
spindle density
Description
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).
Time Frame
12 months after baseline
Title
delta spectral power in slow wave sleep
Description
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).
Time Frame
12 months after baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gilles Boschetti, MD,PhD
Phone
+33 4 78 86 13 02
Email
gilles.boschetti@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Maelys Cheviakoff
Phone
+33 4 78 86 37 66
Email
maelys.cheviakoff01@chu-lyon.fr
Facility Information:
Facility Name
CHU Clermont-Ferrand, Hôpital d'Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63100
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony BUISSON
Facility Name
CHU Grenoble Hôpital Michallon-Site Nord
City
Grenoble
ZIP/Postal Code
38700
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolas MATHIEU
Facility Name
Lyon Sud hospital
City
Pierre-Bénite
ZIP/Postal Code
69310
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gilles BOSCHETTi, MD,PhD
Facility Name
CHU Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42270
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Roblin

12. IPD Sharing Statement

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

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