Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 10:19 PM
Study NCT ID:
NCT05956158
Status:
RECRUITING
Last Update Posted:
2025-10-31
First Post:
2023-06-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
RISE: A Remote Study of Insomnia Treatment in Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2026-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-29', 'studyFirstSubmitDate': '2023-06-22', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2025-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in C-reactive protein', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'We will measure blood levels of C-reactive protein'}, {'measure': 'Change in fecal calprotectin', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'We will measure levels of fecal calprotectin via a stool sample.'}, {'measure': 'Change in sleep architecture', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'We will measure changes in percent time spent in light sleep, deep sleep, and rapid eye movement (REM) sleep using the Oura ring.'}, {'measure': 'Change in behaviorally assessed pain tolerance via the Cold Pressor Test', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': "The Cold Pressor Test involves submerging one's non-dominant hand in ice water and rating discomfort at regular, pre-determined intervals. Pain tolerance will be measured based on the total amount of time a participant can keep their hand submerged, with a maximum of 3 minutes."}, {'measure': 'Change in diary-based sleep efficiency', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'Change in sleep efficiency (total sleep time / time in bed), derived from a self-reported sleep diary.'}, {'measure': 'Change in objective sleep onset latency', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'Change in the time it takes to fall asleep each night, derived from the Oura ring.'}, {'measure': 'Change in objective wake after sleep onset', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'Change in the time spent awake in the middle of the night, derived from the Oura ring.'}, {'measure': 'Change in objective sleep efficiency', 'timeFrame': 'Baseline, 8 weeks, and 21 weeks', 'description': 'Change in sleep efficiency (total sleep time / time in bed), derived from the Oura ring.'}], 'primaryOutcomes': [{'measure': 'Feasibility of the intervention as measured by attrition rate over time', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'Attrition rate will be based on the percentage of participants who have dropped out of the trial at different time points.'}, {'measure': 'Feasibility of the intervention as measured by recruitment rate over time', 'timeFrame': 'From study initiation until we are no longer actively recruiting (approximately 24 months)', 'description': 'Recruitment rate will be based on the number of participants who are recruited into the trial per month.'}, {'measure': 'Feasibility of the intervention as measured by assessment completion at multiple time points', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'Assessment completion rate will be based on the percentage of participants who complete all the required questionnaires and tasks at each time point.'}, {'measure': 'Feasibility of the intervention as measured by qualitative interviews', 'timeFrame': '8 weeks and 34 weeks', 'description': 'Feasibility will be based on interview-derived themes related to barriers and facilitators to study engagement. Data will be collected at two time points to ensure completeness of themes.'}, {'measure': 'Acceptability of the intervention as measured by visit completion', 'timeFrame': '8 weeks', 'description': 'Visit completion will be based the number of visits (out of 5) completed by each participant.'}, {'measure': 'Treatment acceptability questionnaire score', 'timeFrame': '1 week', 'description': 'The Treatment Acceptability Questionnaire is a 4-item self-report questionnaire designed to assess the overall acceptability of an intervention. Scores range from 1 to 4 and higher scores are indicative of greater acceptability.'}, {'measure': 'Acceptability of the intervention as measured by qualitative interviews', 'timeFrame': '8 weeks', 'description': 'Acceptability will be based on interview-derived themes related to aspects of the intervention that participants found helpful and unhelpful.'}], 'secondaryOutcomes': [{'measure': 'Change in insomnia symptoms as measured by the Insomnia Severity Index', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'The Insomnia Severity Index (ISI) is a self-report questionnaire designed to measure severity of insomnia. The ISI is made up of 7 items on insomnia symptoms and related impairments and total scores range from 0-28. Higher scores are indicative of greater insomnia symptoms.'}, {'measure': 'Change in diary-based sleep onset latency', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'A weekly average of self-reported time it takes to fall asleep each night, derived from a self-reported sleep diary'}, {'measure': 'Change in diary-based wake after sleep onset', 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': 'A weekly average of self-reported time spent awake in the middle of each night, derived from a self-reported sleep diary'}, {'measure': "Change in Crohn's disease symptoms as measured by the Patient Reported Outcomes 3", 'timeFrame': 'Baseline, 8 weeks, 21 weeks, and 34 weeks', 'description': "The Patient Reported Outcomes 3 (PRO-3) is a self-report questionnaire designed to measure the severity of Crohn's disease symptoms in the past week. The PRO-3 is made up of 3 items (stool frequency, pain, and well-being) and higher scores are indicative of more severe symptoms. Scores are interpreted as follows: \\<13=quiescent or inactive disease; 13-21=mildly active disease; 22-52=moderately active disease; 53 and up=severely active disease."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Insomnia', 'Crohn Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess whether the investigators can treat insomnia in people with Crohn's disease, and if insomnia treatment can make other things better, like pain or inflammation.", 'detailedDescription': "People with Crohn's disease often suffer from sleep problems. Long term, sleep problems may lead to more flares of Crohn's disease or other complications. In general, patients with Crohn's disease also report that sleep problems can worsen symptoms of Crohn's disease the next day. In people with other medical problems, research has also shown that having sleep problems can make other things worse, such as pain and inflammation. In this study, the investigators want to understand if they can treat sleep problems in people with Crohn's disease, and what else might improve if sleep gets better. If this study is successful, it will help the investigators understand more about how to treat insomnia in people with Crohn's disease and how sleep impacts pain and inflammation. Long term, this information will be helpful in understanding how best to take care of people with Crohn's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mild to moderate CD based on PRO-3 \\& 50% with objective evidence of active disease\n* Insomnia Severity Index score ≥ 8 and SOL or WASO ≥ 30 minutes\n* Stability of sleep \\& CD meds for ≥ 3 months\n* Access to internet or cell phone service sufficient for telehealth\n\nExclusion Criteria:\n\n* PHQ-9 depression score ≥ 15\n* GAD-7 anxiety score ≥ 15\n* Unstable major psychiatric condition (e.g., bipolar disorder, psychotic disorder)\n* Current alcohol or substance abuse\n* Current opioid use for pain control\n* Current systemic corticosteroid use\n* Current pregnancy or nursing\n* Ileostomy or colostomy\n* Diagnosis of seizure disorder\n* Diagnosis of sleep apnea or positive WatchPAT screen\n* Diagnosis of restless leg syndrome or positive Cambridge-Hopkins RSLq screen\n* Night shift, rotating shift work, or frequent travel outside of time zone'}, 'identificationModule': {'nctId': 'NCT05956158', 'acronym': 'RISE', 'briefTitle': "RISE: A Remote Study of Insomnia Treatment in Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': "RISE: A Remote Study of Insomnia Treatment in Crohn's Disease", 'orgStudyIdInfo': {'id': 'STUDY02001855'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Behavioral Treatment', 'interventionNames': ['Behavioral: Behavioral Treatment']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Sleep Education Treatment', 'interventionNames': ['Behavioral: Sleep Education Treatment']}], 'interventions': [{'name': 'Behavioral Treatment', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive Behavioral Therapy for Insomnia', 'CBT-I'], 'description': 'This treatment is designed to help participants make changes to behavior patterns and thoughts that contribute to insomnia.', 'armGroupLabels': ['Behavioral Treatment']}, {'name': 'Sleep Education Treatment', 'type': 'BEHAVIORAL', 'description': "This treatment is designed to help participants understand the relationships among sleep, pain, and Crohn's disease and to make changes to insomnia-related behaviors.", 'armGroupLabels': ['Sleep Education Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03756', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jessica K Salwen-Deremer, PhD', 'role': 'CONTACT', 'email': 'jessica.k.salwen-deremer@hitchcock.org', 'phone': '603-650-6388'}], 'facility': 'Dartmouth-Hitchcock Medical Center', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Psychiatry & Medicine', 'investigatorFullName': 'Jessica.K.Salwen-Deremer', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}