Ignite Creation Date:
2025-12-26 @ 12:17 PM
Ignite Modification Date:
2025-12-26 @ 12:17 PM
Study NCT ID:
NCT04299100
Status:
COMPLETED
Last Update Posted:
2021-12-10
First Post:
2019-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sleep Health Program for Patients With Chronic Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012891', 'term': 'Sleep Apnea Syndromes'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D001049', 'term': 'Apnea'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D020919', 'term': 'Sleep Disorders, Intrinsic'}, {'id': 'D020920', 'term': 'Dyssomnias'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-09', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2020-03-03', 'lastUpdatePostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Sleep Health Program', 'timeFrame': '8 weeks', 'description': 'Proportion of participants at baseline, and who completed the follow-up visits at 8 weeks.'}, {'measure': 'Feasibility of Sleep Health Program', 'timeFrame': '6 months', 'description': 'Proportion of participants at baseline, and who completed the follow-up visits at 6 months.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of Sleep Health Program on Functional Outcomes of Sleep Questionnaire-10.', 'timeFrame': '6 months', 'description': 'Change from baseline in sleep scores on the Functional Outcomes of Sleep-10 questionnaire at 8 weeks and 6 months. Score range: 0-40, lower score indicates worse functional outcomes.'}, {'measure': 'Efficacy of Sleep Health Program on Insomnia Severity Index', 'timeFrame': '6 months', 'description': 'Change from baseline in Insomnia Severity Index score at 8 weeks and 6 months. Score range: 0-28, higher score indicates greater insomnia severity.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sleep Disordered Breathing', 'Chronic Pain', 'Sleep']}, 'descriptionModule': {'briefSummary': 'This is a pilot, prospective, randomized controlled trial of a novel sleep health program versus no sleep intervention in chronic pain patients. The Sleep Health program will consist of weekly home-based videos and digital materials termed "Self-Management for Sleep Care", which will provide participants with information on how to improve their sleep through education on sleep hygiene, relaxation training, and cognitive behavioural components. Patients will be also be screened through undiagnosed sleep apnea. For those determined to have suspected undiagnosed moderate or severe sleep apnea, they will be receive a recommendation for referral to a sleep clinic as part of standard of care. The study aims to evaluate the feasibility and effectiveness of the Sleep Health Program which includes the videos and digital materials and screening for sleep apnea in patients with chronic pain.', 'detailedDescription': 'All participants will complete sleep, pain, and functional questionnaires. Additionally, all participants will undergo one overnight oximetry reading using the wristwatch pulse oximetry. Following these baseline assessments and questionnaires, participants will be randomized to either the control group or the Sleep Health Program.\n\nA)Sleep Health Program Group Participants in this group will receive usual care from their pain physician. Participants will also receive the Self-Management for Sleep Care videos and digital materials. Participants with suspected moderate/severe sleep apnea as determined by oximetry, but who have not been diagnosed with sleep apnea prior to the study, will be recommended for referral to a sleep clinic as part of standard of care.\n\nB)Control Group Participants in this group will receive usual care from their pain physician.\n\nFirst follow up visit:\n\nAt 8 weeks after the initial visit, all participants will attend their first follow-up visit and complete the sleep, pain and functional questionnaires and 7-day sleep diary recording, and report any changes in medications.\n\nSecond follow up visit:\n\nAt 6 months after the initial visit, all participants will attend their second follow-up visit and complete the sleep, pain and functional questionnaires, 7-day sleep diary recording and report any changes in medications. Control participants will receive information provided by the Self-Management for Sleep Care program. Control participants with suspected undiagnosed moderate/severe sleep apnea will be recommended for referral to a sleep clinic as part of standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nThe inclusion criteria are:\n\n* Adult patients (≥18 years old) with cognitive capability\n* Diagnosed with chronic non-cancer pain for \\> 3 months\n* Reports sleep disturbances such as difficulty falling asleep, staying asleep, or problems waking up too early (responds "Mild", "Moderate", "Severe", or "Very Severe" to items 1, 2, or 3 on the Insomnia Severity Index).\n\nExclusion Criteria:\n\n* Patients with chronic pain secondary to a neoplasm or metastasis\n* Conditions potentially interfering with comprehension and delivery of informed consent, such as certain neurological or psychiatric disorders\n* Patients with severe insomnia (Insomnia Severity Index ≥ 22)\n* Restless legs syndrome\n* Periodic limb movement disorder\n* Sleep apnea\n* Narcolepsy\n* Seizure disorder\n* Patients who are pregnant\n* Currently undergoing a psychological treatment for insomnia\n* Participants who require an urgent sleep physician referral (within four weeks) due to serious medical conditions or safety critical-occupations according to the 2011 Canadian Thoracic Society (CTS) guidelines (e.g. unstable ischemic heart disease, recent cerebrovascular disease, congestive heart failure, refractory systemic hypertension, pulmonary hypertension, hypercapnia respiratory failure).'}, 'identificationModule': {'nctId': 'NCT04299100', 'briefTitle': 'Sleep Health Program for Patients With Chronic Pain', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Sleep Health Program for Patients With Chronic Pain: A Pilot Randomized Controlled Trial (S-Health)', 'orgStudyIdInfo': {'id': 'Version: Sep 15, 2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Participants randomized to the Control Group will receive usual care from their pain physician.'}, {'type': 'EXPERIMENTAL', 'label': 'Sleep Health Program - Suspected No/mild sleep apnea', 'description': 'Participants randomized to the Sleep Health Program with no/mild sleep apnea.', 'interventionNames': ['Behavioral: Sleep Health Program for Participants with No/Mild Sleep Apnea']}, {'type': 'EXPERIMENTAL', 'label': 'Sleep Health Program - Suspected Moderate/severe sleep apnea', 'description': 'Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea.', 'interventionNames': ['Behavioral: Sleep Health Program for Participants with Moderate/Severe Sleep Apnea']}], 'interventions': [{'name': 'Sleep Health Program for Participants with No/Mild Sleep Apnea', 'type': 'BEHAVIORAL', 'otherNames': ['Sleep Health group'], 'description': 'Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.', 'armGroupLabels': ['Sleep Health Program - Suspected No/mild sleep apnea']}, {'name': 'Sleep Health Program for Participants with Moderate/Severe Sleep Apnea', 'type': 'BEHAVIORAL', 'otherNames': ['Sleep Health group'], 'description': 'Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea will receive the Self-Management for Sleep Care videos and digital materials, and be recommended for referral to a sleep clinic as part of standard of care.', 'armGroupLabels': ['Sleep Health Program - Suspected Moderate/severe sleep apnea']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5G 2A2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehab Institute (TRI)', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5S 1B2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "Women's College hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T2S8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Western Hopsital, Pain Clinic, Dept. of Anesthesia', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital, Department of Anesthesia', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Frances Chung, MBBS FRCPC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UHN/ University Health Network'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'collaborators': [{'name': 'MOUNT SINAI HOSPITAL', 'class': 'OTHER'}, {'name': 'Unity Health Toronto', 'class': 'OTHER'}, {'name': "Women's College Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, University of Toronto', 'investigatorFullName': 'Dr. Frances Chung', 'investigatorAffiliation': 'University Health Network, Toronto'}}}}