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Sleepwell for Chronic Insomnia (YAWNS NB Trial)

N/A
Waitlist Available
Led By David M Gardner, PharmD
Research Sponsored by David Gardner
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

YAWNS NB Trial 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
  • Chronic Insomnia

YAWNS NB Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants discontinuing BZRA treatment within 6 months
Secondary outcome measures
Number of participants discontinuing BZRA treatment within 3 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
Other outcome measures
Number of participants reporting having a fall (subjective)
Number of participants reporting having a fall-related health visit
Number of visits to mysleepwell.ca website
+10 more

YAWNS NB Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: SleepwellExperimental Treatment1 Intervention
Mailed information package includes 2 Sleepwell booklets (How to get your sleep back and How to stop sleeping pills)
Group II: EmpowerActive Control1 Intervention
Mailed information package includes 2 Empower booklets (You may be at risk AND How to get a good night's sleep without sleeping pills)
Group III: TAUActive Control1 Intervention
Treatment-as-usual group: no mailed intervention package.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sleepwell
2020
N/A
~600

Find a Location

Who is running the clinical trial?

David GardnerLead Sponsor
University of New BrunswickOTHER
22 Previous Clinical Trials
1,964 Total Patients Enrolled
Dalhousie UniversityOTHER
169 Previous Clinical Trials
403,060 Total Patients Enrolled
~130 spots leftby Jun 2025