About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Virtual reality relaxation intervention