Virtual Reality Relaxation for Insomnia

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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

Eligibility

Primary outcome measure(s)

• Pre-Sleep Arousal — Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
  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.

Trial sites (1)

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