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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
iVR Trial 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.Check my eligibility
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.See study design
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.
iVR Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am 18 years old or older.
iVR Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Daily Electronic Sleep/Pain Diaries
Fatigue Severity Scale
Insomnia Severity Index
+3 moreSecondary outcome measures
Beck Depression Inventory Second Edition
Cognitive Failures Questionnaire
Computerized Cognitive Assessments - Sternberg tasks
+5 moreiVR 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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Virtual Reality Mediated Relaxation
2020
N/A
~30
Find a Location
Who is running the clinical trial?
University of Missouri-ColumbiaLead Sponsor
365 Previous Clinical Trials
628,207 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had trouble sleeping for over 6 months, affecting my daily life.I have been experiencing pain and trouble sleeping for over 6 months.I am not currently participating in any non-drug treatments for pain, sleep, fatigue, or mood.I have trouble sleeping, including falling asleep, staying asleep, or waking up too early.I have been experiencing pain and trouble sleeping for over 6 months.My insomnia affects my mood, thinking, social life, or work.My insomnia affects my mood, thinking, social life, or work.I have been diagnosed with insomnia.I have cognitive issues that make it hard for me to understand or follow treatment plans.I have had trouble sleeping for over 6 months despite having the chance to sleep.I have had trouble sleeping for over 6 months and it affects my day.Your screening test shows a score of 11 or higher on the ISI scale.You experience sleep problems even when you have had enough time and conditions for sleeping.I have trouble falling or staying asleep, wake up too early, or don't feel rested after sleeping.You have a serious mental health condition that is not being treated.I am unable to understand or sign the consent form.I have a sleep disorder other than insomnia, like severe sleep apnea or PLMD.I have bipolar or seizure disorder.I am 18 years old or older.You have a major mental health condition other than depression or anxiety, like having thoughts of hurting yourself or others, or having psychotic disorders.I am taking medication that affects my pain or sleep.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Reality Based Relaxation Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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