Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study (NCT04253691) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
United States30 participantsStarted 2020-02-09
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18+ years,
✓. able to read and understand English,
✓. pain and insomnia complaints for 6+ months,
✓. diagnosed with (4.1) insomnia based on the criteria below:
✓.1) insomnia complaints for 6+ months that:
✓.1a) occur despite adequate opportunity and circumstances for sleep, and
✓.1b) consist of 1 or more of the following: difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep,
✓.1c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia,
Exclusion criteria
✕. unable to provide informed consent,
✕. unable to complete forms and implement treatment due to cognitive impairment (MMSE\<26),
✕
What they're measuring
1
Daily Electronic Sleep/Pain Diaries
Timeframe: 6 weeks
2
Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset)