Disease BowelRECIDREAMNCT05835973
Evaluation of Sleep Changes in Inflammatory Bowel Diseases (IBD) Patients.
A study testing Sleep activity and Questionnaires in people with Disease Bowel and Crohn Disease, run by Hospices Civils de Lyon at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Disease Bowel, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Sleep activity and Questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 4 sitesFrance
- Study dates
- 8 Apr 2025to 8 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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).
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
CHU Clermont-Ferrand, Hôpital d'Estaing
Clermont-Ferrand, 63100
Anthony BUISSON
- Not yet recruiting
CHU Grenoble Hôpital Michallon-Site Nord
Grenoble, 38700
Nicolas MATHIEU
- Recruiting
Lyon Sud hospital
Pierre-Bénite, 69310
Gilles BOSCHETTi, MD,PhD
- Not yet recruiting
CHU Saint Etienne
Saint-Etienne, 42270
Xavier Roblin
About this study
Official title: 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.
- Conditions
- Disease Bowel, Crohn Disease, Ulcerative Colitis
- Being tested
- Sleep activity, Questionnaires
- Keywords
- Inflammatory Bowel Diseases, Crohn's disease, ulcerative colitis, sleep deprivation, relapse
- Medical subject headings
- Intestinal Diseases, Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Diseases, Sleep Deprivation, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep activityOther
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.
QuestionnairesOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sleep activity | Experimental | 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. Receives: Other: Sleep activity; Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after baseline
Secondary outcomes (10)
Sleep efficiency calculated by actimetry and expressed in percentage.
Patient will wear actimeters on the wrist for 1 year continuously.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2023
- Study start8 Apr 2025
- Primary completion8 Apr 2028 (estimated)
- Study completion8 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disease BowelStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05835973
- Sponsor's protocol ID
- 69HCL22_0907
- Acronym
- RECIDREAM
- Status last verified
- Nov 2025
- First submitted
- 19 Apr 2023
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Changes as Early Markers of Relapse in Patients With Inflammatory Bowel Diseases (IBD).
- ClinicalTrials.gov ID
- NCT05835973
- Acronym / sponsor ID
- RECIDREAM / 69HCL22_0907
- Conditions
- Disease Bowel, Crohn Disease, Ulcerative Colitis
- Keywords
- Inflammatory Bowel Diseases, Crohn's disease, ulcerative colitis, sleep deprivation, relapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 8 Apr 2028 (estimated)
- Study completion
- 8 Jun 2028 (estimated)
- First posted
- 28 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sleep activity | Experimental | Other: Sleep activity, Other: QuestionnairesActigraphy : 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
- Patient must sign informed consent form to participate to the study.
- Patient affiliated to or benefiting from a social security plan.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep activityActinography : 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 | Sleep activity |
| QuestionnairesThe 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. | Other | Sleep activity |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep activity and Questionnaires in people with Disease Bowel and Crohn Disease, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gilles Boschetti, MD,PhD (+33 4 78 86 13 02, gilles.boschetti@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of relapse (time frame: 12 months after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.