Virtual Reality Relaxation for Insomnia
ConditionInsomnia Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-50
SponsorLaval University
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Virtual reality relaxation intervention
DeviceA 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.
Treatment groups
30 Participants
are divided into 2 treatment groupsGroup A: Waitlist control groupOther 1 intervention
Group B: TreatmentExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).Secondary outcomes
1
Insomnia severity
The Insomnia Severity Index (ISI) is a self-administered questionnaire used to assess the severity of insomnia. The ISI consists of seven items that evaluate the nature, intensity, and consequences of insomnia over the past month. The dimensions assessed include difficulties initiating or maintaining sleep (sleep onset latency, nighttime awakenings, early morning awakenings), dissatisfaction with sleep, the impact of sleep difficulties on daytime functioning, and the level of distress caused by these problems. Each item is rated on a 5-point Likert scale from 0 (not at all) to 4 (extremely), yielding a total score ranging from 0 to 28. Interpretation thresholds are as follows: 0-7 (no clinically significant insomnia), 8-14 (subthreshold insomnia), 15-21 (moderate insomnia), and 22-28 (severe insomnia).
Time frame
Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).2
Anxiety
The Beck Anxiety Inventory (BAI) will be used to assess participants' anxiety symptoms. The BAI consists of 21 items rated on a Likert scale from 0 (Not at all) to 3 (Severely - It bothered me a lot). The total score is calculated by summing the responses to all 21 items (0-7 points are considered to reflect a minimal level of anxiety; scores of 8-15 indicate mild anxiety; scores of 16-25 reflect moderate anxiety; and scores of 26-63 indicate severe anxiety).
Time frame
Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).3
Depression
The Beck Depression Inventory - Second Edition (BDI-II) is a self-administered questionnaire designed to assess the severity of depressive symptoms. It consists of 21 items corresponding to various depressive symptoms, each rated on a four-point Likert scale from 0 (least severe) to 3 (most severe). The total score ranges from 0 to 63, with higher scores indicating greater severity of depressive symptoms.
Time frame
Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).4
Sleep health
The Ru-SATED scale is a self-report questionnaire that assesses six dimensions of sleep health. It evaluates regularity (i.e., going to bed and waking up at about the same time each day), satisfaction with sleep, alertness (i.e., the ability to stay awake without dozing off during the day), timing (i.e., typically being in bed between 2:00 and 4:00 a.m.), efficiency (i.e., spending less than 30 minutes awake per night), and sleep duration (i.e., sleeping between 7 and 9 hours per night). Each dimension is rated on a five-point Likert scale from 0 (never) to 4 (always). The total score, obtained by summing the scores across the six dimensions, ranges from 0 to 24, with higher scores indicating better sleep health.
Time frame
Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).Other outcomes
1
Acceptability of the intervention
Participants will complete a brief acceptability questionnaire based on the Theoretical Framework of Acceptability (TFA). The questionnaire includes eight items assessing the following constructs: affective attitude, perceived burden, ethicality, perceived effectiveness, intervention coherence, self-efficacy, opportunity costs, and overall acceptability. All items are rated on a 5-point Likert scale ranging from 1 to 5, with response anchors varying by item (e.g., strongly disagree to strongly agree, or not at all appreciated to strongly appreciated). Higher scores indicate greater acceptability, except for items assessing perceived burden and opportunity costs, for which higher scores reflect greater burden or interference with other priorities.
Time frame
End of intervention (Week 4).2
Retention
Retention is defined as the proportion of participants who complete the 4-week intervention and all associated assessments, including Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Time frame
12 weeks after end of intervention (Week 16).3
Intervention adherence
Intervention adherence is defined as the total number of intervention sessions completed over the 4-week intervention period.
Time frame
End of intervention (Week 4).Sponsors and contacts
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Source ClinicalTrials.gov