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Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study

NCT04253691 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-22

No results posted yet for this study

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).

Conditions

  • Insomnia Chronic
  • Pain, Chronic

Interventions

DEVICE

Virtual Reality Mediated Relaxation

Participants will use a brief Virtual Reality relaxation protocol to improve their insomnia. Their workbook will contain a handout that outlines the details. Participants will be encouraged to refer to it at home if they forget any part of the procedure.

Sponsors & Collaborators

  • University of Missouri-Columbia

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-09
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04253691 on ClinicalTrials.gov