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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Sleep efficiency calculated by actimetry and expressed in percentage. | Patient will wear actimeters on the wrist for 1 year continuously. | 12 months after baseline |
| Intra-sleep wakefulness duration (min), sleep latency (min) and sleep duration (min) |
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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:
Patient must sign informed consent form to participate to the study.
Patient affiliated to or benefiting from a social security plan.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gilles Boschetti, MD,PhD | Contact | +33 4 78 86 13 02 | gilles.boschetti@chu-lyon.fr | |
| Maelys Cheviakoff | Contact | +33 4 78 86 37 66 | maelys.cheviakoff01@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Clermont-Ferrand, Hôpital d'Estaing | Not yet recruiting | Clermont-Ferrand | 63100 | France |
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| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| D012892 | Sleep Deprivation |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D005759 | Gastroenteritis |
| D003092 | Colitis |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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|
| 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. |
|
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.
| 12 months after baseline |
| total sleep time | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| sleep onset latency | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| intra-sleep wake duration | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| polysomnographic sleep efficiency | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| quantity of different sleep stages | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| index of micro-arousals | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| spindle density | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| delta spectral power in slow wave sleep | Sleep parameters evaluated by headband are:
| 12 months after baseline |
| CHU Grenoble Hôpital Michallon-Site Nord | Not yet recruiting | Grenoble | 38700 | France |
|
| Lyon Sud hospital | Recruiting | Pierre-Bénite | 69310 | France |
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| CHU Saint Etienne | Not yet recruiting | Saint-Etienne | 42270 | France |
|
| D003108 |
| Colonic Diseases |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |