Clinical Trial

Virtual Reality Relaxation for Insomnia

Recruiting
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Summary
The goal of this clinical trial is to evaluate the feasibility, acceptability, and preliminary effects of a virtual reality (VR) relaxation intervention among adults aged 25 to 50 with insomnia disorder. The main questions this study aims to address are: * Is a VR relaxation intervention feasible to implement and acceptable for individuals with insomnia? * Does the intervention reduce pre-sleep cognitive and somatic arousal? * Does the intervention improve sleep quality and sleep depth? * Can the intervention enhance overall sleep health and reduce symptoms of insomnia, anxiety, and depression? * Are these potential benefits maintained at a 3-month follow-up? Participants will be randomly assigned to either the intervention group or a waitlist control group. Researchers will compare outcomes between groups to evaluate the impact of the intervention. Participants will: * Complete online questionnaires at three time points (baseline, post-intervention, and 3-month follow-up) assessing sleep health, pre-sleep arousal, and symptoms of insomnia, anxiety, and depression * Take part in an in-person diagnostic interview at Université Laval to assess sleep and mental health status * Complete a daily online sleep diary for 8 weeks (2 weeks baseline, 4 weeks intervention, and 2 weeks post-intervention) * Engage in a 15-minute VR-guided meditation session each evening at home for 4 weeks * Wear a portable sleep monitor at home for 8 nights (4 nights baseline and 4 nights post-intervention) * Complete an acceptability questionnaire following the intervention
Trial Details
NCT Number NCT07630532
Lead Sponsor Laval University
Conditions Insomnia Disorder
Enrollment 30 participants
Start Date 2025-09-01
Primary Completion 2027-01 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2026-06-05