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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

Sleep disturbances are common among chronic pain patients, with reports typically ranging from 50-70% of patients reporting sleep difficulties. It is well documented that, alongside a high comorbidity with chronic pain, chronic insomnia also has high comorbidity with, and is a risk factor for, developing an anxiety disorders. This clinical trial will examine the effects of virtual reality (VR) meditation environments on patients with pain- and insomnia-related anxiety. The purpose of this study is to examine the benefits of using VR meditation with patients with chronic pain and chronic sleep disturbance so that clinicians can more effectively treat core causes to symptoms and reduce counterproductive therapies. Research objectives include: 1. To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain. 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 clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health. 4. To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).

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 data supports the effectiveness of the treatment Virtual Reality Mediated Relaxation for chronic insomnia?

Research suggests that virtual reality (VR) can help reduce bedtime arousal, which is a common issue in insomnia, by providing a calming, immersive experience. A study on a VR-based mind-body approach showed preliminary data supporting its potential to help adolescents with insomnia relax before sleep. ^{1 2 3 4 5}

Is virtual reality relaxation safe for humans?

The research does not provide specific safety data for virtual reality relaxation for chronic insomnia, but virtual reality-based therapies are generally considered safe for humans, with some studies suggesting they can help reduce stress and anxiety. ^{1 3 6 7 8}

How is Virtual Reality Mediated Relaxation different from other treatments for chronic insomnia?

Virtual Reality Mediated Relaxation is unique because it uses immersive virtual reality technology to create a mind-body approach that helps reduce bedtime arousal, which is a common issue in insomnia. This digital and immersive experience is different from traditional treatments like cognitive behavioral therapy or medication, as it focuses on creating a calming environment through virtual reality to help improve sleep. ^{1 3 4 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A virtual reality-based mind-body approach to downregulate psychophysiological arousal in adolescent insomnia. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Insomnia in the Digital Age. [2020]

3. United States 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. [2022]

4. United States 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. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

The effects of a sleep robot intervention on sleep, depression and anxiety in adults with insomnia - Study protocol of a randomized waitlist-controlled trial. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating the Efficacy of Electrical Vestibular Stimulation (VeNS) on Insomnia Adults: Study Protocol of a Double-Blinded, Randomized, Sham-Controlled Trial. [2023]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Digital cognitive behavioral therapy for insomnia - The first Georgian version. Can we use it in practice? [2020]

8. England pubmed.ncbi.nlm.nih.gov

PreScription DigitaL ThErapEutic for Patients with Insomnia (SLEEP-I): a protocol for a pragmatic randomised controlled trial. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Online Delivery of Cognitive Behavioral Therapy-Insomnia: Considerations and Controversies. [2019]