Virtual Reality Relaxation for Chronic Insomnia

(iVR Trial)

Overseen By Angelynn Simenson, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Missouri-Columbia

Must not be taking: Psychotropics, Beta-blockers

Disqualifiers: Cognitive impairment, Sleep apnea, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether virtual reality (VR) meditation can reduce anxiety and improve sleep in individuals with chronic pain and insomnia. The researchers aim to determine if VR relaxation techniques, specifically Virtual Reality Mediated Relaxation, can address the underlying causes of sleep issues and pain, potentially reducing reliance on less effective treatments. It is best suited for those experiencing pain and insomnia for over six months, who often struggle with falling asleep, staying asleep, or waking up too early, impacting their daily life. As an unphased study, this trial provides a unique opportunity to explore innovative solutions for improving sleep and managing chronic pain.

Will I have to stop taking my current medications?

The trial requires that participants do not take psychotropic or other medications that alter pain or sleep, such as beta-blockers.

What prior data suggests that this virtual reality relaxation technique is safe for patients with chronic pain and insomnia?

Research has shown that virtual reality (VR) for relaxation is generally well-received by patients. Studies have found that VR can reduce anxiety and sleep problems without causing major side effects. In one study, patients found VR mindfulness helpful for treating insomnia and easy to use.

Another study demonstrated that a two-week VR relaxation and mindfulness program significantly reduced anxiety and sleep issues, indicating it is both helpful and safe.

Overall, VR relaxation therapies are considered safe, with very few reports of negative effects. This makes VR a promising option for managing ongoing insomnia and anxiety related to pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Virtual Reality Mediated Relaxation for chronic insomnia because it offers a fresh approach that differs from standard treatments like medication or cognitive-behavioral therapy. Unlike traditional methods, this treatment uses immersive virtual reality technology to promote relaxation and improve sleep quality, potentially making it more engaging and accessible. Additionally, it avoids the side effects often associated with sleep medications and provides a non-pharmacological option, which is increasingly important for patients seeking holistic health solutions.

What evidence suggests that virtual reality relaxation is effective for chronic insomnia?

Studies have shown that virtual reality (VR) can assist people with sleep difficulties and anxiety. VR-based relaxation and mindfulness exercises quickly ease these symptoms. Research indicates that VR therapy improves sleep quality and reduces feelings of depression and anxiety. Both patients and doctors consider this method effective for treating sleep problems. Overall, VR relaxation offers a promising new way to help those struggling with ongoing sleep issues and anxiety. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

Adults over 18 with chronic insomnia and pain for more than 6 months, who have trouble sleeping or feel unrested despite having the chance to sleep, and experience daytime issues because of it. They must understand English and score ≥11 on the ISI screening. Excluded are those with other sleep disorders, severe mental health conditions, cognitive impairments, or taking certain medications.

Inclusion Criteria

I have had trouble sleeping for over 6 months, affecting my daily life.

I have been experiencing pain and trouble sleeping for over 6 months.

able to read and understand English

Exclusion Criteria

I am not currently participating in any non-drug treatments for pain, sleep, fatigue, or mood.

I have cognitive issues that make it hard for me to understand or follow treatment plans.

You have a serious mental health condition that is not being treated.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo Virtual Reality Based Relaxation Therapy for chronic insomnia and pain-related anxiety

6 weeks

Weekly virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality Mediated Relaxation

Trial Overview The study is testing if virtual reality meditation can help people with chronic pain and insomnia by improving their sleep quality, reducing pain and fatigue, enhancing mood and daily function, as well as bettering cognitive abilities and heart health.

How Is the Trial Designed?

Group I: Virtual Reality Based Relaxation Therapy Experimental Treatment 1 Intervention

This is a pilot trial with one treatment condition (VR mediation).

Who Is Running the Clinical Trial?

University of Missouri-Columbia

Lead Sponsor

Trials

387

Recruited

629,000+

Published Research Related to This Trial

In a study involving 270 participants at a Fortune 500 company, digital cognitive behavioral therapy (dCBT) significantly improved sleep quality, with a large effect size (Cohen's d of 1.10) compared to a waiting list group.

Participants who underwent dCBT also showed notable improvements in work productivity, particularly in reducing presenteeism, indicating that better sleep can enhance workplace performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep and Productivity Benefits of Digital Cognitive Behavioral Therapy for Insomnia: A Randomized Controlled Trial Conducted in the Workplace Environment. Bostock, S., Luik, AI., Espie, CA.[2022]

The Sleep Scholar intervention, a self-guided online program for insomnia, was found to be feasible and acceptable among college students with a history of suicidal ideation and insomnia symptoms, with 38 participants completing the study.

Participants reported positive satisfaction with the program, and post-treatment analyses indicated clinically significant reductions in mental health symptoms, suggesting potential benefits for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of sleep scholar: A single-session, internet-based insomnia intervention for college students with a history of suicide ideation. Crosby Ms Msw, ES., Witte PhD, TK.[2023]

A multicentre randomized controlled trial is being conducted with 100 participants to evaluate the effectiveness of a prescription digital therapeutic (PDT) called Somryst, which delivers cognitive behavioural therapy for insomnia (CBT-I) via mobile devices.

The primary goal is to measure changes in insomnia severity after 9 weeks, while secondary outcomes will assess healthcare utilization and various patient-reported outcomes, including depressive symptoms and daytime sleepiness, providing comprehensive insights into the PDT's real-world impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. Dreyer, RP., Berkowitz, A., Yaggi, HK., et al.[2023]

Cognitive behavioral therapy for insomnia (CBT-I) is the preferred treatment for insomnia, but its use is limited due to a shortage of trained therapists and high costs, leading to the development of Internet and mobile versions of CBT-I.

While digital CBT-I has shown promising results, challenges such as high dropout rates and the need for more advanced technology for fully automated solutions remain, highlighting the need for further research and development in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in the Digital Age. Kang, SG., Kim, YK.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39213857/

Virtual reality improves sleep quality and associated ... Our findings offered preliminary evidence that VR therapy enhanced sleep quality and also lessened depressive and anxious symptoms.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04253691

Sleep Intervention for Chronic Insomnia Using Virtual ... The aim of this study is to investigate the benefits of replacing treatment as usual (TAU) relaxation practices, with Virtual Reality (VR) mediation ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11440031/

Acute Augmented Effect of Virtual Reality (VR)–Integrated ... Two‐week augmented VR‐integrated relaxation and mindfulness exercising is acutely beneficial for relieving both anxiety and insomnia symptoms.

4. sciencedirect.com sciencedirect.com/science/article/pii/S169726002500081X

The acceptability of virtual reality mindfulness for the ... This study aimed to (1) assess the acceptability of VR mindfulness for the treatment of insomnia from clinicians and patients with chronic insomnia, and (2) ...

5. withpower.com withpower.com/trial/phase-sleep-initiation-and-maintenance-disorders-1-2020-d43f1

Virtual Reality Relaxation for Chronic Insomnia (iVR Trial) 2. To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.3. To examine changes in the secondary ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12204043/

Impact of Virtual Reality–Based Biofeedback on Sleep ... Our hypothesis posited that VR-based BF would demonstrate superior efficacy in enhancing sleep quality compared to conventional BF among ...