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Protocol - Your Answers When Needing Sleep in New Brunswick

NCT04406103 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 594

Last updated 2023-09-07

No results posted yet for this study

Summary

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.

Sleeping 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.

Cognitive 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.

Internationally, 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.

This study will evaluate the effectiveness of direct-to-patient interventions on long-term sleeping pill use.

Conditions

  • Insomnia Chronic

Interventions

BEHAVIORAL

Sleepwell

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

BEHAVIORAL

Empower

Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.

Sponsors & Collaborators

  • University of New Brunswick

    collaborator OTHER

  • Dalhousie University

    collaborator OTHER

  • David Gardner

    lead OTHER

Principal Investigators

  • David M Gardner, PharmD · Dalhousie University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-06
Primary Completion
2022-10-31
Completion
2023-03-30

Countries

  • Canada

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04406103 on ClinicalTrials.gov