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NCT04253691 · ClinicalTrials.gov registry record · NA

Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study

A NA study of Pain, Chronic and Insomnia Chronic, sponsored by University of Missouri-Columbia.

Active
Registry status
NA
Development phase
30
Enrollment target
1
Study location

NCT04253691: Active NA study of Pain, Chronic and Insomnia Chronic, sponsored by University of Missouri-Columbia.

NCT04253691 is a NA study of Pain, Chronic and Insomnia Chronic that is active but no longer recruiting, run by University of Missouri-Columbia. The registered enrollment target is 30 participants, below the 721-participant average among 48 other Pain, Chronic trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04253691, a NA study of Pain, Chronic and Insomnia Chronic, is active but no longer recruiting, sponsored by University of Missouri-Columbia.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
30 participants
Enrollment target
1
Study location

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).

Primary Outcome

Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption

Interventions

  • DEVICE Virtual Reality Mediated Relaxation

Study Locations (1)

Missouri

  • University of Missouri - Columbia

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2020-02-09
Est. Completion 2025-12-30
Phase NA
University of Missouri-Columbia

291 total trials

What the registry record for NCT04253691 still lists

NCT04253691 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 721-participant average among 48 other Pain, Chronic trials with a reported enrollment target (96% lower).

The record links to 2 conditions, with Pain, Chronic appearing as the primary indexed condition, and to 1 intervention - of which Virtual Reality Mediated Relaxation is the first listed.

NCT04253691 reports a single indexed study location in Missouri.

Frequently Asked Questions

What is clinical trial NCT04253691 about?

NCT04253691 is a clinical study titled "Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study". 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, devel...

What is the current status of trial NCT04253691?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 30 participants. The study started on 2020-02-09. Estimated completion is 2025-12-30.

What conditions does trial NCT04253691 study?

This clinical trial studies the following conditions: Pain, Chronic, Insomnia Chronic.

What interventions are being tested in trial NCT04253691?

The interventions under investigation include: Virtual Reality Mediated Relaxation (DEVICE).

Who is sponsoring clinical trial NCT04253691?

This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04253691 being conducted?

This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain, Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04253691's enrollment target sits among peer trials

30 40th of 48 higher than 6 of 48 other Pain, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04253691, the US trial registry maintained by the National Library of Medicine. NCT04253691 (small enrollment · single site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.