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Virtual Reality Relaxation for Chronic Insomnia (iVR Trial)

N/A
Waitlist Available
Research Sponsored by University of Missouri-Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosed with insomnia based on specific criteria: complaints for 6+ months despite adequate opportunity for sleep, difficulty falling asleep, staying asleep, waking up too early, nonrestorative sleep, daytime dysfunction due to insomnia, screening ISI score ≥ 11
4.1c) daytime dysfunction (mood, cognitive, social, occupational) due to insomnia
Must not have
Unable to complete forms and implement treatment due to cognitive impairment (MMSE<26)
Unable to provide informed consent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial will examine the effects of virtual reality (VR) meditation environments on patients with pain- and insomnia-related anxiety.

Who is the study for?
Adults over 18 with chronic insomnia and pain for more than 6 months, who have trouble sleeping or feel unrested despite having the chance to sleep, and experience daytime issues because of it. They must understand English and score ≥11 on the ISI screening. Excluded are those with other sleep disorders, severe mental health conditions, cognitive impairments, or taking certain medications.
What is being tested?
The study is testing if virtual reality meditation can help people with chronic pain and insomnia by improving their sleep quality, reducing pain and fatigue, enhancing mood and daily function, as well as bettering cognitive abilities and heart health.
What are the potential side effects?
While not explicitly stated in the provided information, potential side effects may include discomfort from wearing VR equipment or temporary disorientation after use. However, VR interventions are generally considered low-risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had trouble sleeping for over 6 months, affecting my daily life.
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My insomnia affects my mood, thinking, social life, or work.
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My insomnia affects my mood, thinking, social life, or work.
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I have had trouble sleeping for over 6 months despite having the chance to sleep.
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I have had trouble sleeping for over 6 months and it affects my day.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have cognitive issues that make it hard for me to understand or follow treatment plans.
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I am unable to understand or sign the consent form.
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I have a sleep disorder other than insomnia, like severe sleep apnea or PLMD.
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I have bipolar or seizure disorder.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Daily Electronic Sleep/Pain Diaries
Fatigue Severity Scale
Insomnia Severity Index
+3 more
Secondary study objectives
Beck Depression Inventory Second Edition
Cognitive Failures Questionnaire
Computerized Cognitive Assessments - Sternberg tasks
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Virtual Reality Based Relaxation TherapyExperimental Treatment1 Intervention
This is a pilot trial with one treatment condition (VR mediation).

Find a Location

Who is running the clinical trial?

University of Missouri-ColumbiaLead Sponsor
379 Previous Clinical Trials
628,464 Total Patients Enrolled

Media Library

Virtual Reality Mediated Relaxation Clinical Trial Eligibility Overview. Trial Name: NCT04253691 — N/A
Chronic insomnia Research Study Groups: Virtual Reality Based Relaxation Therapy
Chronic insomnia Clinical Trial 2023: Virtual Reality Mediated Relaxation Highlights & Side Effects. Trial Name: NCT04253691 — N/A
Virtual Reality Mediated Relaxation 2023 Treatment Timeline for Medical Study. Trial Name: NCT04253691 — N/A
~1 spots leftby Dec 2024
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