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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 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.

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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).

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

Sponsor

University of Missouri-Columbia

291 total trials

What the Registry Record Tells You About NCT04253691

The ClinicalTrials.gov registry entry for NCT04253691 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 721-participant average among 48 other Pain, Chronic trials with a reported enrollment target (96% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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