Virtual Reality Relaxation for Insomnia

NCT07630532 | Recruiting

• 1 other identifier: 2025-113/14-05-2025
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Pre-Sleep Arousal

  The Pre-Sleep Arousal Scale (PSAS) is a 16-item questionnaire that assesses symptoms of cognitive (e.g., racing thoughts, worry about not falling asleep) and somatic arousal (e.g., muscle tension, rapid heartbeat) experienced at bedtime. Participants rate the intensity of each symptom as they attempt to fall asleep using a five-point Likert scale ranging from 1 (not at all) to 5 (extremely). Higher scores on the scale indicate elevated levels of pre-sleep arousal.

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

Secondary Outcomes (7)

• Insomnia severity

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

• Anxiety

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

• Depression

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

• Sleep health

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

• Positive and negative emotions

  Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).

Other Outcomes (3)

• Acceptability of the intervention

  End of intervention (Week 4).

• Retention

  12 weeks after end of intervention (Week 16).

• Intervention adherence

  End of intervention (Week 4).

Study Arms (2)

Waitlist control group

OTHER

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.

Device: Virtual reality relaxation intervention

Treatment

EXPERIMENTAL

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.

Device: Virtual reality relaxation intervention

Interventions

Virtual reality relaxation intervention DEVICE

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.

Also known as: VR relaxation intervention

Treatment; Waitlist control group

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead

Study Sites (1)

Laval University

Québec, Quebec, G1V 0A6, Canada

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Hypoventilation

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Célyne H Bastien, PhD

  Laval University

  STUDY DIRECTOR

Central Study Contacts

William-Girard Journault, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: June 5, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Time Frame: Beginning 3 months after publication with no end date.
• Access Criteria: Data will be made available upon reasonable request, and applicants will be required to submit a brief research proposal outlining the purpose of the data use. Access will be granted only after approval by the study investigators and completion of a data-sharing agreement ensuring appropriate use, confidentiality, and data protection. Data will be shared through secure, password-protected electronic transfer.

Locations

CA (1)