MedTrace Logo

Virtual Reality Relaxation for Insomnia

NCT07630532 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-06-05

No results posted yet for this study

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

Conditions

  • Insomnia Disorder

Interventions

DEVICE

Virtual reality relaxation intervention

A virtual reality (VR) intervention combining guided sleep-focused meditation and slow breathing will be used to provide an immersive relaxation experience. Each evening, participants will complete a 15-minute mindfulness meditation accompanied by visual animations designed to guide slow, paced breathing. The meditation content aims to cultivate present-moment awareness and facilitate the release of sleep-related negative thoughts and cognitive arousal. All sessions will be completed in a seated position before bedtime, aligned with each participant's typical sleep schedule. The immersive experience will be delivered using a Meta Quest 3 VR headset configured with a low-blue-light display mode.

Sponsors & Collaborators

  • Laval University

    lead OTHER

Principal Investigators

  • Célyne H Bastien, PhD · Laval University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2027-01-31
Completion
2027-09-30

Countries

  • Canada

Study Locations

More Related Trials

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 NCT07630532 on ClinicalTrials.gov