Virtual Reality Relaxation for Insomnia

Laval University

Status: Enrolling

Conditions: Insomnia Disorder

Treatments: Device: Virtual reality relaxation intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT07630532

2025-113/14-05-2025

Details and patient eligibility

About

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

Full description

The objective of this study is to evaluate the feasibility and acceptability of a virtual-reality relaxation intervention for individuals with insomnia disorder, and to assess its effects on pre-sleep arousal, sleep quality, mental health, and sleep depth. The intervention is expected to lead to high feasibility and acceptability, a reduction in cognitive and somatic pre-sleep arousal, a decrease in sleep latency, wake after sleep onset, and number of awakenings, as well as an increase in sleep efficiency. Reductions in insomnia severity, anxiety symptoms, and depressive symptoms are also expected. In addition, variables derived from the Odds Ratio Product (ORP)-a validated index of sleep depth ranging from 0 (deep sleep) to 2.5 (wake)-will be computed. It is anticipated that the intervention will increase the total time spent in deep sleep (ORP 0-0.5) and decrease gamma power (>35 Hz), alpha intrusion (i.e., the number of three-second epochs with alpha power > 30 µV²), and the time required for sleep depth to recover following an awakening (ORP-9).

An open-label, parallel-group, randomized controlled trial will be conducted to evaluate the feasibility, acceptability, and efficacy of the intervention. Thirty participants (15 women) aged 25 to 50 will be recruited following a diagnostic interview for insomnia (EDI-A) and psychiatric disorders (MINI). Insomnia severity (ISI), somatic and cognitive arousal (PSAS), and symptoms of anxiety (BAI) and depression (BDI-II) will be assessed using validated questionnaires. Participants will complete a daily sleep diary, and the Prodigy 2 Sleep Monitor, which enables home-based polysomnography (PSG), will be used to assess sleep quality and sleep depth. Feasibility outcomes (recruitment, retention, and adherence) and acceptability of the intervention, assessed through a self-reported questionnaire based on the Theoretical Framework of Acceptability, will complement the study measures.

The virtual-reality intervention consists of a 15-minute guided meditation adapted for sleep and combined with slow breathing (~6 breaths per minute) to promote immersive relaxation. Sessions will be performed in a seated position before bedtime, aligned with each participant's usual sleep schedule. The guided meditation, developed in collaboration with the McGill Mindfulness Research Lab, aims to enhance present-moment awareness and reduce negative sleep-related thoughts. The immersive environment was created in partnership with OVA, a Quebec-based company specializing in relaxing immersive environments, using visuals (starry night), ambient neutral soundscapes, and gender-neutral, accessible narration. Immersion will be delivered using a Meta Quest 3 headset configured to minimize exposure to blue light.

After providing informed consent and completing the diagnostic interview, eligible participants will complete psychological questionnaires, a two-week sleep diary, and four nights of home PSG at baseline [T1]. Participants will then be randomly assigned to the intervention group or the waitlist control group. The intervention group will complete the daily VR intervention for four weeks, after which both groups will undergo a second assessment [T2]. The waitlist group will then receive the VR intervention for four weeks, followed by its own post-intervention assessment. A three-month follow-up assessment will be conducted for both groups to evaluate whether the effects of the intervention are sustained over time.

Enrollment: 30 estimated patients

Sex: All

Ages: 25 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Waitlist control group

Other group

Description:

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.

Treatment:

Device: Virtual reality relaxation intervention

Treatment

Experimental group

Description:

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.

Treatment:

Device: Virtual reality relaxation intervention