Testing Virtual reality relaxation intervention for insomnia disorder
Official title: Virtual Reality Relaxation for Insomnia
Virtual Reality Relaxation Intervention for Individuals With Insomnia
- 2 groups
- One site, in Québec
- Recruiting
Interventions
- Medical device
Virtual reality 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.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
Laval University
Québec, Quebec
Eligibility Criteria
See who this study is looking for8 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −Currently using prescription or over-the-counter sleep aids
- −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)
- −Engaged in night shifts or rotating shift work
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Groups A and B receive Virtual reality relaxation intervention.
Registry label: A: Waitlist control group · B: Treatment
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 25 years to 50 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 30 people.
The study is currently expected to finish around September 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Pre-Sleep Arousal — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16).
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07630532 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Virtual reality relaxation interventionDevice
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.
From the trial registry — its own words, unedited.
What a device is here: A physical instrument, implant, app or piece of equipment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 25 years to 50 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 25 years to 50 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → (Day 1), end of intervention (Week 4), and 12 weeks after end of intervention (Week 16)..
The study as a whole is currently expected to finish around 2027-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 30 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Québec, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.