← Back to all trials
Recruiting
NCT07630532
Virtual Reality Relaxation for Insomnia
Conditions: Insomnia Disorder
Sex: All
Ages: 25 Years – 50 Years
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: Laval University
Location: Laval University Québec Quebec
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 Criteria
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
Source: ClinicalTrials.gov (NCT07630532). StuddyBuddy aggregates publicly available trial information.