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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Waitlist control group | Other | 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. |
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| Treatment | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality relaxation intervention | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William-Girard Journault, BA | Contact | 581-998-6713 | william-girard.journault.1@ulaval.ca |
| Name | Affiliation | Role |
|---|---|---|
| Célyne H Bastien, PhD | Laval University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University | Recruiting | Québec | Quebec | G1V 0A6 | Canada |
The data sets to be shared will include all de-identified individual participant data that underlie the results reported in future publications arising from this study. This will include de-identified questionnaire responses, sleep diary data, and objective sleep measures collected through the portable sleep monitor.
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Beginning 3 months after publication with no end date.
Data will be made available upon reasonable request, and applicants will be required to submit a brief research proposal outlining the purpose of the data use. Access will be granted only after approval by the study investigators and completion of a data-sharing agreement ensuring appropriate use, confidentiality, and data protection. Data will be shared through secure, password-protected electronic transfer.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| D007040 | Hypoventilation |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| 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). | Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| 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. | Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| 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. | Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| Positive and negative emotions | The Positive and Negative Affect Schedule (PANAS) is a self-report questionnaire used to assess the intensity of affective states. The instrument consists of 20 adjectives, with 10 describing positive affect and 10 describing negative affect. Participants rate, on a five-point Likert scale ranging from 1 (very slightly or not at all) to 5 (extremely), the extent to which they experience each emotion. A high score on the positive affect subscale reflects a state of high energy and pleasurable emotions, while a high score on the negative affect subscale indicates subjective distress involving multiple negative emotions. | Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| Sleep characters recorded by sleep diary | Participants will record sleep diaries each day duration the 4-week of intervention. Participants will complete 14-day sleep diaries at baseline before recruitment, end of intervention and 12 weeks after end of intervention. The following parameters extracted from the diary will be used for analysis: sleep latency (the time in minutes required to transition from wakefulness to sleep), number of awakenings (the count of nocturnal awakenings lasting more than 5 minutes), wake after sleep onset (the total time in minutes spent awake after initially falling asleep and before final awakening), and sleep efficiency (the proportion of total sleep time relative to time spent in bed). | Baseline (Day 1), intervention (Weeks 1-4), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16). |
| Sleep characters recorded by a portable sleep monitor | A portable sleep monitor (Prodigy 2 Sleep Monitor) will be used to collect objective measures of sleep quality. The following parameters recorded from the sleep monitor will be used for analysis: sleep latency (the time in minutes required to transition from wakefulness to sleep), number of awakenings (the count of nocturnal awakenings lasting more than 5 minutes), wake after sleep onset (the total time in minutes spent awake after initially falling asleep and before final awakening), and sleep efficiency (the proportion of total sleep time relative to time spent in bed). | Four consecutive nights at baseline and four consecutive nights at the end of the intervention (Week 4). |
| End of intervention (Week 4). |
| 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). | 12 weeks after end of intervention (Week 16). |
| Intervention adherence | Intervention adherence is defined as the total number of intervention sessions completed over the 4-week intervention period. | End of intervention (Week 4). |
| D001523 |
| Mental Disorders |
| D012131 | Respiratory Insufficiency |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |