Insomnia ChroniciVRNCT04253691
Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
A study testing Virtual Reality Mediated Relaxation in people with Insomnia Chronic and Pain, Chronic, run by University of Missouri-Columbia at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia Chronic, Pain, Chronic
- What is being tested?
- Virtual Reality Mediated Relaxation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2020to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- unable to provide informed consent,
- unable to complete forms and implement treatment due to cognitive impairment (MMSE<26),
- sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI>15], Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour > 15]),
- bipolar or seizure disorder (due to risk of sleep restriction treatment),
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders),
- severe untreated psychiatric comorbidity,
- psychotropic or other medications (e.g., beta-blockers) that alter pain or sleep,
- participation in any nonpharmacological treatment (including CBT) for pain, sleep, fatigue or mood outside the current study
Trial locations and contacts
1 site in 1 country.
About this 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, 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:
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
- To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).
Read the detailed description
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. Research has shown that Cognitive Behavioral Therapies (CBT) are efficacious in treating patient with comorbid insomnia and chronic pain (e.g., improvements in sleep parameters, normal sleep efficiency, reductions in pain severity. CBT addresses a number of factors involved in the maintenance of patient sleep and health issues, and a key piece of CBT for insomnia and pain is the reduction of worrisome thoughts, or anxiety related to sleep and pain issues. A common evidence-based strategy used for reducing anxiety and worry is the practice of relaxation. The aim of this study is to investigate the benefits of replacing treatment as usual (TAU) relaxation practices, with Virtual Reality (VR) mediation environments within CBT treatment.
Virtual Reality Meditation for Anxiety
There are few studies in the literature demonstrating a relationship between Virtual Reality (VR) - a computer generated environment that presents the user with a realistic three-dimensional space - and reductions in anxious symptomology. However, the results of those studies are very encouraging. In a case study, Tarrant and Cope treated 4 firefighters who had anxiety and anxiety-based disorders with a Positivity VR Experience. 3 of 4 treated patients exhibited increased left gamma symmetry, associated with approach behavior and increased mood, and 3 of 4 patients showed increases in State-Cheerfulness and Positive Affect. Tarrant and colleagues also conducted a pilot study, where they treated 14 patients who had moderate or higher levels of generalized anxiety with a 5-minute Mindfulness in Nature experience. Patients in the VR meditation group showed both global and regional decreases in Beta activity (i.e., decrease in frequencies associated with qualitatively anxious states and decreased self-reported State Anxiety. Overall, these results seem promising, as they provide preliminary evidence supporting that VR interventions may be a useful and effective tool for the treatment of elevated anxiety symptoms.
In summary, this clinical trial will examine the effects of VR meditation environments on patients with pain- and insomnia-related anxiety. The proposed study design will yield important information about the efficacy of VR meditation practices. 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.
Ultimately, this research targets two important public health concerns, namely insomnia and chronic pain. Insomnia in the context of chronic pain has been relatively understudied. Thus, the results of the present study will provide unique insights into sleep and chronic pain and will advance knowledge in the fields of both sleep and pain. Although the results of this study will be specific to chronic pain patients, they will have broader implications for other medical populations likely to suffer from chronic pain and insomnia (i.e., cancer patients, older adults). The information gained has the potential to make a significant contribution to behavioral healthcare practices for a wide variety of disorders, not just insomnia and pain. Thus, this research has implications not only for future sleep and pain research but also for other types of treatment-related research.
- Objectives
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
- To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).
- Conditions
- Insomnia Chronic, Pain, Chronic
- Being tested
- Virtual Reality Mediated Relaxation
- Keywords
- Sleep, Pain, Virtual Reality
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Chronic Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Mediated RelaxationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Based Relaxation Therapy | Experimental | This is a pilot trial with one treatment condition (VR mediation). Receives: Device: Virtual Reality Mediated Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily Electronic Sleep/Pain Diaries
Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset)
Objective wake after sleep onset
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 (Sleep Onset Latency)
Objective sleep onset latency
Measured: 6 weeks
Objective Daily Sleep Actiwatch-2 (Sleep Efficiency)
Objective sleep efficiency
Measured: 6 weeks
Insomnia Severity Index
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Measured: 6 weeks
Fatigue Severity Scale
Fatigue severity; min:10 max: 73; higher score means higher fatigue severity
Measured: 6 weeks
Secondary outcomes (8)
Patient centered outcomes questionnaire
The Patient Centered Outcomes questionnaire assesses four domains (pain, fatigue, emotional distress, and interference with daily activities) relevant to chronic pain populations on a numerical rating scale ranging from 0-10; min: 0 max:200; 200; A greater score equates a worse outcome
Measured: 6 weeks
Computerized Cognitive Assessments -WCST
Determine level of cognitive functioning
Measured: 6 weeks
Computerized Cognitive Assessments - Stroop Task
Determine level of cognitive functioning
Measured: 6 weeks
Computerized Cognitive Assessments - Sternberg tasks
Determine level of cognitive functioning
Measured: 6 weeks
List learning-Rey Auditory Learning Test modified for visual presentation
Immediate and delayed recall memory
Measured: 6 weeks
Beck Depression Inventory Second Edition
Depressive symptom assessment; min: 0 max: 63; Higher score means higher severity of depression
Measured: 6 weeks
State Trait Anxiety Inventory
Assessment of Anxiety symptoms; mix: 0 max:60; higher score means higher anxiety
Measured: 6 weeks
Cognitive Failures Questionnaire
Self-reported failures in perception, memory, and motor function; min:0 max: 100; higher score means greater cognitive failure
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start9 Feb 2020
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christina McCrae, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04253691
- Sponsor's protocol ID
- 2017122
- Acronym
- iVR
- Status last verified
- Apr 2026
- First submitted
- 16 Jan 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Tarrant J, Viczko J, Cope H. Virtual Reality for Anxiety Reduction Demonstrated by Quantitative EEG: A Pilot Study. Front Psychol. 2018 Jul 24;9:1280. doi: 10.3389/fpsyg.2018.01280. eCollection 2018.
PubMed 30087642Thompson, M., & Thompson, L. (2007). Neurofeedback for stress management. Principles and practice of stress management, 3, 249-287.
Tarrant, J., & Cope, H. (2018). Combining frontal gamma asymmetry neurofeedback with virtual reality: A proof-of-concept case study. NeuroRegulation, 5(2), 57-66. https://doi.org/10.15540/nr.5.2.57
Sutton, S. K., & Davidson, R. J. (1997). Prefrontal Brain Asymmetry: A Biological Substrate of the Behavioral Approach and Inhibition Systems. Psychological Science, 8(3), 204-210. https://doi.org/10.1111/j.1467-9280.1997.tb00413.x
Price, J., & Budzynski, T. (2009). Anxiety, EEG patterns, and neurofeedback. Introduction to quantitative EEG and neurofeedback: Advanced theory and applications, 453-470.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Intervention for Chronic Insomnia Using Virtual Reality Pilot Study
- ClinicalTrials.gov ID
- NCT04253691
- Acronym / sponsor ID
- iVR / 2017122
- Conditions
- Insomnia Chronic, Pain, Chronic
- Keywords
- Sleep, Pain, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 9 Feb 2020 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
- To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).
Detailed description
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. Research has shown that Cognitive Behavioral Therapies (CBT) are efficacious in treating patient with comorbid insomnia and chronic pain (e.g., improvements in sleep parameters, normal sleep efficiency, reductions in pain severity. CBT addresses a number of factors involved in the maintenance of patient sleep and health issues, and a key piece of CBT for insomnia and pain is the reduction of worrisome thoughts, or anxiety related to sleep and pain issues. A common evidence-based strategy used for reducing anxiety and worry is the practice of relaxation. The aim of this study is to investigate the benefits of replacing treatment as usual (TAU) relaxation practices, with Virtual Reality (VR) mediation environments within CBT treatment.
Virtual Reality Meditation for Anxiety
There are few studies in the literature demonstrating a relationship between Virtual Reality (VR) - a computer generated environment that presents the user with a realistic three-dimensional space - and reductions in anxious symptomology. However, the results of those studies are very encouraging. In a case study, Tarrant and Cope treated 4 firefighters who had anxiety and anxiety-based disorders with a Positivity VR Experience. 3 of 4 treated patients exhibited increased left gamma symmetry, associated with approach behavior and increased mood, and 3 of 4 patients showed increases in State-Cheerfulness and Positive Affect. Tarrant and colleagues also conducted a pilot study, where they treated 14 patients who had moderate or higher levels of generalized anxiety with a 5-minute Mindfulness in Nature experience. Patients in the VR meditation group showed both global and regional decreases in Beta activity (i.e., decrease in frequencies associated with qualitatively anxious states and decreased self-reported State Anxiety. Overall, these results seem promising, as they provide preliminary evidence supporting that VR interventions may be a useful and effective tool for the treatment of elevated anxiety symptoms.
In summary, this clinical trial will examine the effects of VR meditation environments on patients with pain- and insomnia-related anxiety. The proposed study design will yield important information about the efficacy of VR meditation practices. 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.
Ultimately, this research targets two important public health concerns, namely insomnia and chronic pain. Insomnia in the context of chronic pain has been relatively understudied. Thus, the results of the present study will provide unique insights into sleep and chronic pain and will advance knowledge in the fields of both sleep and pain. Although the results of this study will be specific to chronic pain patients, they will have broader implications for other medical populations likely to suffer from chronic pain and insomnia (i.e., cancer patients, older adults). The information gained has the potential to make a significant contribution to behavioral healthcare practices for a wide variety of disorders, not just insomnia and pain. Thus, this research has implications not only for future sleep and pain research but also for other types of treatment-related research.
- Objectives
- To examine the clinical and health characteristics, including sleep, pain, fatigue, cognitive abilities, and cardiovascular health in patients with chronic pain.
- To examine changes in the primary clinical outcomes, including chronic pain, complaints of poor sleep, and fatigue.
- To examine changes in the secondary clinical outcomes, including mood, daytime functioning, cognitive functioning, and cardiovascular health.
- To examine the mechanistic variables, including arousal (heart rate variability, HRV) and CS (thermal response).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Based Relaxation Therapy | Experimental | Device: Virtual Reality Mediated RelaxationThis is a pilot trial with one treatment condition (VR mediation). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- unable to provide informed consent,
- unable to complete forms and implement treatment due to cognitive impairment (MMSE<26),
- sleep disorder other than insomnia (i.e., sleep apnea [apnea/hypopnea index, AHI>15], Periodic Limb Movement Disorder-PLMD [myoclonus arousals per hour > 15]),
- bipolar or seizure disorder (due to risk of sleep restriction treatment),
- other major psychopathology except depression or anxiety (e.g., suicidal ideation/intent, psychotic disorders),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Mediated RelaxationParticipants 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. | Device | Virtual Reality Based Relaxation Therapy |
Primary outcome
Daily Electronic Sleep/Pain Diaries
Time frame: 6 weeks
Daily electronic dairies will record pain intensity and unpleasantness, sleep (latency, wake after onset, efficiency, quality), fatigue, sleep and pain medication consumption
Objective Daily Sleep Actiwatch-2 (Wake After Sleep Onset)
Time frame: 6 weeks
Objective wake after sleep onset
Objective Daily Sleep Actiwatch-2 (Sleep Onset Latency)
Time frame: 6 weeks
Objective sleep onset latency
Objective Daily Sleep Actiwatch-2 (Sleep Efficiency)
Time frame: 6 weeks
Objective sleep efficiency
Insomnia Severity Index
Time frame: 6 weeks
Insomnia severity measurement; min: 0 max:28; higher score means greater insomnia severity
Fatigue Severity Scale
Time frame: 6 weeks
Fatigue severity; min:10 max: 73; higher score means higher fatigue severity
8 secondary outcomes
Patient centered outcomes questionnaire
Time frame: 6 weeks
Computerized Cognitive Assessments -WCST
Time frame: 6 weeks
Computerized Cognitive Assessments - Stroop Task
Time frame: 6 weeks
Computerized Cognitive Assessments - Sternberg tasks
Time frame: 6 weeks
List learning-Rey Auditory Learning Test modified for visual presentation
Time frame: 6 weeks
Beck Depression Inventory Second Edition
Time frame: 6 weeks
State Trait Anxiety Inventory
Time frame: 6 weeks
Cognitive Failures Questionnaire
Time frame: 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Background: PubMed 30087642Tarrant J, Viczko J, Cope H. Virtual Reality for Anxiety Reduction Demonstrated by Quantitative EEG: A Pilot Study. Front Psychol. 2018 Jul 24;9:1280. doi: 10.3389/fpsyg.2018.01280. eCollection 2018.
- BackgroundThompson, M., & Thompson, L. (2007). Neurofeedback for stress management. Principles and practice of stress management, 3, 249-287.
- BackgroundTarrant, J., & Cope, H. (2018). Combining frontal gamma asymmetry neurofeedback with virtual reality: A proof-of-concept case study. NeuroRegulation, 5(2), 57-66. https://doi.org/10.15540/nr.5.2.57
- BackgroundSutton, S. K., & Davidson, R. J. (1997). Prefrontal Brain Asymmetry: A Biological Substrate of the Behavioral Approach and Inhibition Systems. Psychological Science, 8(3), 204-210. https://doi.org/10.1111/j.1467-9280.1997.tb00413.x
- BackgroundPrice, J., & Budzynski, T. (2009). Anxiety, EEG patterns, and neurofeedback. Introduction to quantitative EEG and neurofeedback: Advanced theory and applications, 453-470.
Related trials for Insomnia Chronic
Enrolling by invitation
Physical Activity Interventions for Sleep Improvement and Sedative-Hypnotic Reduction in Middle-Aged and Older Adults: Investigating the Role of Sarcopenia
Insomnia Chronic, Hypnotics and Sedatives
Active, not recruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
Chronic Insomnia, Chronic Pain
Recruiting
Clinical Efficacy of Thumbtack Needle for Chronic Insomnia in Perimenopausal and Menopausal Women
Chronic Insomnia During Perimenopause and Menopause
Not yet recruiting
Online Tai Chi Versus Digital CBT-I for Chronic Insomnia
Chronic Insomnia Disorder
Not yet recruiting
Shiwei Anshen Granules for Chronic Insomnia
Chronic Insomnia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Mediated Relaxation in people with Insomnia Chronic and Pain, Chronic, run by University of Missouri-Columbia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily Electronic Sleep/Pain Diaries (time frame: 6 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04253691, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 2 Nov 2026.