Virtual Reality Relaxation for Insomnia (NCT07630532)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (6 items).
Location: Laval University — Québec, Quebec
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Diagnosis of serious medical conditions (e.g., cancer, neurological disorders, chronic pain) or major psychiatric disorders
- Conditions that could be exacerbated by virtual reality devices (e.g., epilepsy, eye disorders, dizziness, balance disorders)
- Adverse effects related to virtual reality use (e.g., dizziness, nausea)
- Currently using prescription or over-the-counter sleep aids
- Engaged in night shifts or rotating shift work
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Laval University — Québec, Quebec
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.