Ignite Creation Date:
2025-12-24 @ 7:43 PM
Ignite Modification Date:
2026-02-25 @ 8:18 PM
Study NCT ID:
NCT04406103
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2020-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protocol - Your Answers When Needing Sleep in New Brunswick
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007319', 'term': 'Sleep Initiation and Maintenance Disorders'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 594}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-05', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-26', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Score on the Beliefs about Medicines Questionnaire (BMQ)', 'timeFrame': 'baseline, 6 months', 'description': 'BMQ'}, {'measure': 'Number of visits to mysleepwell.ca website', 'timeFrame': '6 months', 'description': 'The count of website visits by study participants in the Sleepwell arm during 6 months'}, {'measure': 'Time to fall asleep (minutes)', 'timeFrame': 'baseline, 6 mo.', 'description': 'Sleep onset latency (SOL) measured in minutes'}, {'measure': 'Time spent asleep (minutes)', 'timeFrame': 'baseline, 6 months', 'description': 'Total sleep time (TST) measured in minutes'}, {'measure': 'Sleep efficiency (%)', 'timeFrame': 'baseline, 6 months', 'description': 'Time spent sleeping (min.) compared to total time spent in bed (min) x 100'}, {'measure': 'Score on the Epworth Sleepiness Scale', 'timeFrame': 'baseline, 6 months', 'description': 'Assessment of daytime sleepiness'}, {'measure': 'Score on the Insomnia Severity Index', 'timeFrame': 'baseline, 6 months'}, {'measure': 'Score on the Generalized anxiety disorder - 7', 'timeFrame': 'baseline, 6 months'}, {'measure': 'Vulnerable elderly survey, 13-item version', 'timeFrame': 'baseline, 6 months', 'description': 'A function-based self-reported brief survey to assess risk of functional decline and death'}, {'measure': 'Score on the Quality of life SF-12v2', 'timeFrame': 'baseline, 6 mo.'}, {'measure': 'Number of participants reporting having a fall (subjective)', 'timeFrame': 'baseline, 6 months'}, {'measure': 'Number of participants reporting having a fall-related health visit', 'timeFrame': 'baseline, 6 months'}, {'measure': 'Responses to the prescriber acceptability survey', 'timeFrame': '6 months', 'description': 'Prescribers will be invited to respond to this end-of-study survey assessing their acceptability of the Sleepwell intervention. The development of this survey was informed by the Theoretical Framework of Acceptability'}], 'primaryOutcomes': [{'measure': 'Number of participants discontinuing BZRA treatment within 6 months', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Number of participants discontinuing BZRA treatment within 3 months', 'timeFrame': '3 months'}, {'measure': 'Number of participants with BZRA dose change of 25% or more within 6 months', 'timeFrame': '6 months', 'description': 'Relative change in BZRA dose between baseline and 6 months is 25% or greater.'}, {'measure': 'Number of participants starting a new non-BZRA sedative-hypnotic', 'timeFrame': '6 months', 'description': 'Newly started on other sedative-hypnotics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['insomnia', 'benzodiazepines', 'deprescribing', 'cognitive-behavioural therapy for insomnia (CBTi)'], 'conditions': ['Insomnia Chronic']}, 'referencesModule': {'references': [{'pmid': '39292452', 'type': 'DERIVED', 'citation': 'Gardner DM, Turner JP, Magalhaes S, Rajda M, Murphy AL. Patient Self-Guided Interventions to Reduce Sedative Use and Improve Sleep: The YAWNS NB Randomized Clinical Trial. JAMA Psychiatry. 2024 Dec 1;81(12):1187-1197. doi: 10.1001/jamapsychiatry.2024.2731.'}, {'pmid': '36045710', 'type': 'DERIVED', 'citation': 'Murphy AL, Turner JP, Rajda M, Magalhaes S, Allen KG, Gardner DM. A protocol for a randomized controlled trial comparing Sleepwell, EMPOWER, and treatment-as-usual for benzodiazepine receptor agonist discontinuation in older adults: the your answers when needing sleep in New Brunswick (YAWNS NB) study. Explor Res Clin Soc Pharm. 2022 Aug 3;7:100164. doi: 10.1016/j.rcsop.2022.100164. eCollection 2022 Sep.'}]}, 'descriptionModule': {'briefSummary': "New Brunswick has an aging population with Canada's highest rate of sleeping pill use. The rate of long-term (chronic) use among NB seniors is 25%, well in excess of the Canadian average of 10%. The rate of use is higher in women and increases with age, as do risks for serious harms.\n\nSleeping pills risks are substantial and costly, especially to seniors. Research does not support their long-term use. Risk for falls causing injuries, including hip fractures, is a leading concern. They impair mental and physical functioning resulting in a loss of independence and cause impaired driving and a higher rate of serious crashes. The rate of near-fatal and fatal overdoses from mixing sleeping pills with other drugs is on the rise. Stopping treatment can be difficult due to physical dependence and withdrawal symptoms.\n\nCognitive behavioural therapy for insomnia (CBTi) is recommended as the first-line treatment of chronic insomnia. Sleeping pills are only to be considered when CBTi fails. However, these recommendations are not reflected in primary care practice.\n\nInternationally, many educational interventions targeting prescribers have been tried, yet have failed to reduce sleeping pill use. However, a 12-page pamphlet (EMPOWER) given directly to seniors in a clinical trial was associated with a large reduction in sleeping pill use. Using a similarly persuasive approach, Sleepwell (mysleepwell.ca) was developed to reduce the use of sleeping pills and facilitate CBTi access and use. Sleepwell differs from EMPOWER by providing specific information and recommendations regarding CBTi in addition to guidance on how to stop sleeping pills.\n\nThis study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.", 'detailedDescription': "The investigators are proposing to investigate direct-to-patient health promotion interventions that promote sleeping pill dose reduction and treatment discontinuation by enhancing self-efficacy through various behaviour change techniques embedded in printed information provided to patients. Seniors will be invited to participate via direct telephone contact, information sharing through seniors' organizations, education sessions for seniors, and public notices. Prospective participants will be given the option of which way they would like to participate in the research:\n\nOption 1: full participation including baseline interview, 6-month interview, and access to specific data from the participant's personal health record); Option 2: limited participation to baseline and 6-month interviews only; and Option 3: limited participation to baseline interview and access to specific data from the participant's personal health record.\n\nThis will form two sets of participants; those who do and those who do not permit access to outcomes from their personal health record. Participants that select Options 1 or 3 will consent to their medication and health resources use being assessed objectively over a six month period. Participants that choose Options 1 or 2 will directly provide baseline information about their health, medication use, and use of health resources via communications with researchers. Similar information will be collected directly from participants in this group after six months.\n\nRandom group allocation:\n\nOptions 1 and 2: i) Sleepwell package; ii) Empower package; iii) No package Option 3: i) Sleepwell package; ii) No package\n\nThe investigators will compare the rates of reducing and stopping sleeping pill use among the different groups over 6 months. Safety outcomes including falls and hospital visits will be measured. The investigators will also track participant access to online CBTi resources using Google Analytics.\n\nEncouraging results from this study of direct-to-patient health promotion regarding insomnia management and sleeping pill use can be utilized repeatedly over time to reach all individuals who could benefit from the intervention, leading a transformational change in insomnia management."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residents of New Brunswick, Canada\n* age 65 or older\n* English speaking\n* community dwelling with no anticipated change of address for the next 6 months\n* current user of BZRAs (3 or more bedtime doses in previous 7 days)\n* long-term user of BZRA: use 3 months or longer\n* BZRA indication: insomnia.\n\nExclusion Criteria:\n\n* using non-BZRA sedative-hypnotics for treating insomnia or related sleep problems (e.g., trazodone, quetiapine, tricyclic antidepressant, mirtazapine, melatonin, diphenhydramine, dimenhyrdinate)\n* use of alcohol or cannabis 3 or more nights a week for sleep problems\n* diagnosis of other sleep disorders: sleep terrors, sleep apnea, restless legs syndrome, narcolepsy, sleepwalking\n* severe anxiety disorder\n* obsessive compulsive disorder\n* severe cognitive impairment\n* dementia\n* seizure disorder\n* spinal injury\n* chronic psychotic disorder (e.g., schizophrenia)\n* bipolar disorder\n* cancer\n* receiving palliative care\n* living in a Long Term Care facility'}, 'identificationModule': {'nctId': 'NCT04406103', 'acronym': 'YAWNS NB', 'briefTitle': 'Protocol - Your Answers When Needing Sleep in New Brunswick', 'organization': {'class': 'OTHER', 'fullName': 'Dalhousie University'}, 'officialTitle': 'Your Answers When Needing Sleep in New Brunswick (YAWNS NB): A Randomized Controlled Trial Comparing Sleepwell, EMPOWER, and Treatment as Usual for Benzodiazepine Receptor Agonist Discontinuation in Older Adults (Protocol)', 'orgStudyIdInfo': {'id': '2020-5184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sleepwell', 'description': 'Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)', 'interventionNames': ['Behavioral: Sleepwell']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Empower', 'description': "Mailed information package includes 2 Empower booklets (You may be at risk AND How to get a good night's sleep without sleeping pills)", 'interventionNames': ['Behavioral: Empower']}, {'type': 'NO_INTERVENTION', 'label': 'TAU', 'description': 'Treatment-as-usual group: no mailed intervention package.'}], 'interventions': [{'name': 'Sleepwell', 'type': 'BEHAVIORAL', 'description': 'Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.', 'armGroupLabels': ['Sleepwell']}, {'name': 'Empower', 'type': 'BEHAVIORAL', 'description': 'Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.', 'armGroupLabels': ['Empower']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E3B 5A3', 'city': 'Fredericton', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'University of New Brunswick'}], 'overallOfficials': [{'name': 'David M Gardner, PharmD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dalhousie University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David Gardner', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of New Brunswick', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'David Gardner', 'investigatorAffiliation': 'Dalhousie University'}}}}