Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
Active, not recruitingNot applicableNCT04253691
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- Official title
- Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
- Conditions
- Insomnia Chronic
- Pain, Chronic
- Interventions
- Device: Virtual Reality Mediated Relaxation
- Sponsor
- University of Missouri-Columbia
- Start date
- 2020-02-09
- Primary completion
- 2026-12-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
General inclusion criteria: 1. 18+ years, 2. able to read and understand English, 3. pain and insomnia complaints for 6+ months, 4. diagnosed with (4.1) insomnia based on the criteria below: 4.1) insomnia complaints for 6+ months that: 4.1a) occur despite adequate opportunity and circumstances for sleep, and 4.1b) consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep, 4.1c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia, 4.1d) screening ISI score ≥ 11 Exclusion criteria: 1. unable to provide informed consent, 2. unable to complete forms and implement treatment due to cognitive impairment (MMSE\<26), 3. sleep disorder other than insomnia (i.e., sleep apnea \[apnea/hypopnea index, AHI\>15\], Periodic Limb Movement Disorder-PLMD \[myoclonus arousals per hour \> 15\]), 4. bipolar or seizure disorder (due to risk of sleep restriction treatment), 5. other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders), 6. severe untreated psychiatric comorbidity, 7. psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep, 8. participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue or mood outside the current study
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04253691