NCT07630532 Virtual Reality Relaxation for Insomnia
| NCT ID | NCT07630532 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laval University |
| Condition | Insomnia Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 30 participants in total. It began in 2025-09-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Inclusion Criteria: * Aged between 25 and 50 years * Experiencing difficulty initiating sleep, maintaining sleep, or early-morning awakenings at least three times per week for a minimum of three months * Residing within a 25-km radius of Université Laval 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
Contact & Investigator
Célyne H Bastien, PhD
STUDY DIRECTOR
Laval University
Frequently Asked Questions
Who can join the NCT07630532 clinical trial?
This trial is open to participants of all sexes, aged 25 Years or older, up to 50 Years, studying Insomnia Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07630532 currently recruiting?
Yes, NCT07630532 is actively recruiting participants. Contact the research team at william-girard.journault.1@ulaval.ca for enrollment information.
Where is the NCT07630532 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT07630532 clinical trial?
NCT07630532 is sponsored by Laval University. The principal investigator is Célyne H Bastien, PhD at Laval University. The trial plans to enroll 30 participants.
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