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Insomnia and Cardiovascular Diseases: Influence of Behavioral Treatments and Preferences

NCT02513017 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2015-07-31

No results posted yet for this study

Summary

Research has shown that persons who have trouble sleeping and experience stress are at risk of developing heart diseases. Two treatments, called stimulus control instructions and sleep efficiency treatment, that do not involve sleeping pills, have been found effective in managing trouble sleeping. This study will be undertaken to find out if the two treatments are effective in improving sleep, and reducing stress and the risk of heart diseases. Persons with trouble sleeping may have a preference for either treatment. It is believed that if persons get the treatment they prefer, then they will be satisfied with the treatment and comply with it, and experience improvement in their sleep. This study will also examine the extent to which giving persons the treatment of their choice, as compared to giving persons treatment based on chance, will lead to higher satisfaction and compliance with treatment, and improved sleep. About 300 persons who experience trouble sleeping will be included in the study. They will be requested to complete a questionnaire and a sleep diary before and after they receive treatment, as well as 6 month and one year later.

Conditions

Interventions

BEHAVIORAL

Stimulus Control Instructions and Sleep Restriction Therapy

Please refer to arm/group descriptions.

Sponsors & Collaborators

  • Toronto Metropolitan University

    lead OTHER

Principal Investigators

  • Dr. Souraya Sidani, PhD · Toronto Metropolitan University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2013-03-31
Completion
2013-03-31

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Entities

Diseases

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 NCT02513017 on ClinicalTrials.gov