← Back to Search

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Do I qualify?Apply below to find out

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

167 Previous Clinical Trials

402,544 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor currently accepting volunteers?

"As reported on clinicaltrials.gov, this investigative trial remains open to enrollees; commencing from November 6th 2020 and most recently updated on May 27th 2022."

Answered by AI

What is the extant number of participants enrolled in this research program?

"Affirmative. Clinicaltrials.gov reveals this clinical trial is actively looking for participants and was first posted on November 6th 2020 with the most recent update being May 27th 2022. To date, 594 patients have been recruited from 1 medical centre."

Answered by AI

Recent research and studies

Exploratory Research in Clinical and Social PharmacyJournal

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

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.

clinicaltrials.govStudy

Protocol - Your Answers When Needing Sleep in New Brunswick

David Gardner 2020. "Protocol - Your Answers When Needing Sleep in New Brunswick". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04406103.