Eligibility
65+
All Sexes
What conditions do you have?
Select
Study Summary
This trial will test whether a 12-page pamphlet called Sleepwell, which provides specific information and recommendations about CBTi and how to stop taking sleeping pills, can reduce the use of sleeping pills among seniors in New Brunswick.
Eligible Conditions
- Sleeplessness
- Insomnia Chronic
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 3 Secondary · Reporting Duration: 6 months
3 months
Number of participants discontinuing BZRA treatment within 3 months
6 months
Number of participants discontinuing BZRA treatment within 6 months
Number of participants starting a new non-BZRA sedative-hypnotic
Number of participants with BZRA dose change of 25% or more within 6 months
Number of visits to mysleepwell.ca website
Responses to the prescriber acceptability survey
baseline, 6 mo.
Score on the Quality of life SF-12v2
Time to fall asleep (minutes)
baseline, 6 months
Number of participants reporting having a fall (subjective)
Number of participants reporting having a fall-related health visit
Score on the Beliefs about Medicines Questionnaire (BMQ)
Score on the Epworth Sleepiness Scale
Score on the Generalized anxiety disorder - 7
Score on the Insomnia Severity Index
Sleep efficiency (%)
Time spent asleep (minutes)
Vulnerable elderly survey, 13-item version
Trial Safety
Safety Progress
Trial Design
3 Treatment Groups
Empower
1 of 3
TAU
1 of 3
Sleepwell
1 of 3
Active Control
Experimental Treatment
594 Total Participants · 3 Treatment Groups
Primary Treatment: Sleepwell · No Placebo Group · N/A
Sleepwell
Behavioral
Experimental Group · 1 Intervention: Sleepwell · Intervention Types: BehavioralEmpower
Behavioral
ActiveComparator Group · 1 Intervention: Empower · Intervention Types: BehavioralTAUNoIntervention Group · 1 Intervention: TAU · Intervention Types:
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 6 months
Who is running the clinical trial?
David GardnerLead Sponsor
University of New BrunswickOTHER
19 Previous Clinical Trials
1,840 Total Patients Enrolled
Dalhousie UniversityOTHER
152 Previous Clinical Trials
340,743 Total Patients Enrolled
David M Gardner, PharmDPrincipal InvestigatorDalhousie University
1 Previous Clinical Trials
106 Total Patients Enrolled
Eligibility Criteria
Age 65+ · All Participants · 7 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:Insomnia is a common side-effect of BZRA.
People who live in New Brunswick, Canada.
You must be 65 years of age or older to participate in this study.
People who have taken Sleeping Pills (BZRAs) three or more times in the last week.
You have been taking BZRA for 3 months or longer.
You are a resident of a community dwelling with no anticipated change of address for the next 6 months.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
References
- Murphy, Andrea L., Justin P. Turner, Malgorzata Rajda, Sandra Magalhaes, Kathleen G. Allen, and David M. Gardner. 2022. “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”. Exploratory Research in Clinical and Social Pharmacy. Elsevier BV. doi:10.1016/j.rcsop.2022.100164.
- David Gardner 2020. "Protocol - Your Answers When Needing Sleep in New Brunswick". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04406103.
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