Insomnia DisorderNCT07630532
Virtual Reality Relaxation for Insomnia
A study testing Virtual reality relaxation intervention in people with Insomnia Disorder, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 50 years
- Conditions the study is for
- Insomnia Disorder
- What is being tested?
- Virtual reality relaxation intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Laval University
Québec, Quebec, G1V 0A6
William-Girard Journault, BA, 581-998-6713, william-girard.journault.1@ulaval.ca
About this study
Official title: Virtual Reality Relaxation Intervention for Individuals With Insomnia
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:
Read more
- 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
Read the detailed description
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.
- Conditions
- Insomnia Disorder
- Being tested
- Virtual reality relaxation intervention
- Keywords
- Insomnia disorder, Hyperarousal, Virtual reality, Polysomnography, Sleep quality, Guided meditation, Slow breathing, Sleep health
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality relaxation interventionDevice
Also called VR 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Virtual reality relaxation intervention |
| 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. Receives: Device: Virtual reality relaxation intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: Four consecutive nights at baseline and four consecutive nights at the end of the intervention (Week 4).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start1 Sep 2025
- Primary completionJan 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insomnia DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Célyne H Bastien, PhD, Study director, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07630532
- Sponsor's protocol ID
- 2025-113/14-05-2025
- Status last verified
- Jun 2026
- First submitted
- 17 Feb 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Relaxation Intervention for Individuals With Insomnia
- ClinicalTrials.gov ID
- NCT07630532
- Acronym / sponsor ID
- 2025-113/14-05-2025
- Conditions
- Insomnia Disorder
- Keywords
- Insomnia disorder, Hyperarousal, Virtual reality, Polysomnography, Sleep quality, Guided meditation, Slow breathing, Sleep health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Waitlist control group | Other | Device: Virtual reality relaxation interventionParticipants 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. |
| Treatment | Experimental | Device: Virtual reality relaxation interventionParticipants 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. |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual reality relaxation interventionAlso: VR relaxation interventionA 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. | Device | Treatment, Waitlist control group |
Primary outcome
Pre-Sleep Arousal
Time frame: 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.
7 secondary outcomes
Insomnia severity
Time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Anxiety
Time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Depression
Time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Sleep health
Time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Positive and negative emotions
Time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
Sleep characters recorded by sleep diary
Time frame: 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
Time frame: Four consecutive nights at baseline and four consecutive nights at the end of the intervention (Week 4).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Célyne H Bastien, PhD study director
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality relaxation intervention in people with Insomnia Disorder, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact William-Girard Journault, BA (581-998-6713, william-girard.journault.1@ulaval.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-Sleep Arousal (time frame: Baseline (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.