Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study

Running, not enrolling · Not applicable

Conditions studied: Insomnia Chronic, Pain, Chronic

In brief

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).

Key facts

Study ID: NCT04253691
Run by: University of Missouri-Columbia
People needed: 30
Starts: 2020-02-09
Expected to finish: 2026-12-30
Last updated by the study team: 2026-04-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

unable to provide informed consent,
unable to complete forms and implement treatment due to cognitive impairment (MMSE<26),
sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI>15], Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour > 15]),
bipolar or seizure disorder (due to risk of sleep restriction treatment),
other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders),
severe untreated psychiatric comorbidity,
psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep,
participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue or mood outside the current study

Where it is running

University of Missouri — Columbia, Missouri, United States

Full record on ClinicalTrials.gov

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