Recruiting

VR Relaxation

Sponsor:

Laval University

Code:

NCT07630532

Conditions

Insomnia Disorder

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Not accepted

Interventions

Virtual reality relaxation intervention

Study Details

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

Conditions

Insomnia Disorder

Study ID

NCT07630532

Start date

Sep 1, 2025

Status verified date

Jun, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 25 - 50

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Waitlist control group

Participants in this arm will not receive the virtual-reality relaxation intervention after the two-week baseline period. Following baseline, they will continue their usual routines for four weeks without making any changes to their sleep or mental health practices. During this waiting period, they will complete the same assessments and daily sleep diary as the intervention group. At the end of the four-week waiting period, they will complete a post-waiting-period (second) assessment. After this assessment is completed, they will then be offered the same four-week virtual-reality relaxation intervention as the treatment group.

experimental: Treatment

Participants in this arm will receive a four week virtual reality relaxation intervention following the two week baseline period. After baseline, they will engage in a 15 minute VR guided meditation session each evening at home for four weeks. At the end of the four week intervention, they will complete a post intervention assessment.

Interventions

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.

Primary outcome measure

  • Pre-Sleep Arousal [ Time Frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). ]

Central Contacts and Locations

Central contacts

William-Girard Journault, BA

581-998-6713william-girard.journault.1@ulaval.ca

Locations

Laval University

Recruiting

Québec, Quebec, Canada, G1V 0A6

Contacts

William-Girard Journault, BA

581-998-6713william-girard.journault.1@ulaval.ca

More Information

Sponsor

Laval University

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Insomnia disorder
  • Hyperarousal
  • Virtual reality
  • Polysomnography
  • Sleep quality
  • Guided meditation
  • Slow breathing
  • Sleep health

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laval University on 2026-06-05.