ClinicalTrials.gg
Status unknownNCT03459274Updated May 31, 2018

Feasibility of an Immersive Virtual Reality Based Biofeedback Intervention for Outpatients in Rheumatology

An observational study in Rheumatoid Arthritis, Systemic Lupus Erythematosus and Spondyloarthropathy, sponsored by Cedars-Sinai Medical Center. Status unknown at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-31.

Sponsored by Cedars-Sinai Medical Center · Observational

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 975 studies in Arthritis, Rheumatoid with a site in United States — 82 open to participants now, 122 under way, 7 of them phase 3. Arthritis, Rheumatoid · United States.

Planned enrollment
183rd of 199
20 · median 200
Started
2018
with 30 others
Observational
201 of 975
29 open now
Registered
720th of 975
by date

Among the 975 studies in Arthritis, Rheumatoid with a site in United States, this one is the 183rd largest by planned enrollment of the 199 observational ones that give a count, is one of 31 that started in 2018, is one of 201 observational ones, and was the 720th registered.

Arthritis, Rheumatoid

3,334 studies on the registry are indexed under Arthritis, Rheumatoid; 444 are open to participants now.

Browse Arthritis, Rheumatoid studies →

Open to participants now

82 of the 975 studies in Arthritis, Rheumatoid with a site in United States are open now. Recruiting first, the newest first:

77 more — sign in →

All 82 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 975 studies in Arthritis, Rheumatoid with a site in United States, or all of them as a file.
02

Study summary

The purpose is to study the use of virtual reality (VR) and biofeedback in rheumatology clinics to help manage chronic pain in patients with rheumatologic diseases. The objective is to know the usefulness of VR/biofeedback-based therapy in the clinic.

03

Conditions studied

  • Rheumatoid Arthritis
  • Systemic Lupus Erythematosus
  • Spondyloarthropathy
  • Vasculitis
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with Rheumatoid arthritis, SLE, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other autoimmune conditions. Patients must be on a stable regimen of medications. Patients should have pain, measured at the time of entry using a Visual Analog scale, of >5/10 at least 4 days in the last 30 days.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Adult patients with Rheumatoid arthritis, Systemic Lupus Erythematosus, Seronegative Spondyloarthropathy, Myositis, Psoriatic Arthritis, vasculitis or other conditions.
  • Patients must be on a stable regimen of medications.
  • Patients should have pain, measured at the time of entry using a Visual Analog scale, of >5/10 at least 4 days in the last 30 days

Exclusion criteria

Exclusion Criteria:

  • Patients who are deemed by the study team to be unable to use the VR headset and follow instructions for any reason.
  • Patients who have a history of vertigo and/or dizziness
  • Patients with a history of seizure disorder
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (estimated)
Patient registry
No

Groups and cohorts

  • VR-Biofeedback Feedback Sharers

    These participants would express either interest or a lack of interest in trying biofeedback/virtual reality therapy. They will be instructed on how to use the virtual reality equipment and program. Then, they will have the option to participate in the biofeedback/virtual reality experience, if they choose to do so, before sharing their feedback.

    Device: VR-Biofeedback

Interventions

  • DeviceVR-Biofeedback

    The intervention uses a smart phone with a virtual reality app; a headset that connects to the phone and has goggles that contribute to the 3 dimensional, interactive, and surrounding aspects of the experience; headphones through which subjects hear calming sounds and guiding voices from the experience; an attached microphone that allows subjects to monitor their breathing and interact with their environment through their breath; and a heart rate monitor whose realtime data on variability has an affect on the virtual environment. The virtual reality experience guides subjects through deep breathing exercises. Subjects will attempt to match a certain slow breathing rate, and pulse and breathing rate will cause non-stressful changes to the environment.

    Also known as: Applied Virtual Reality, Virtual Reality, Biofeedback

06

What researchers measure

Primary outcomes

  1. Self-reported benefit of virtual reality-biofeedback experience

    In interview, subjects are asked to describe their perception of the level of benefit of the Virtual Reality-Biofeedback experience

    Time frame: Within 10 minutes immediately after virtual reality experience completion

Secondary outcomes

  1. Self-reported interest to try the virtual reality-biofeedback experience

    Patients who are consented and fit inclusion criteria are asked, in interview, if they would be interested in trying the virtual reality experience and providing a rationale for their choice.

    Time frame: Within 10 minutes immediately before virtual reality experience start

07

Study locations

1 of 1 sites recruiting
  • Attune Health
    Beverly Hills, California 90024, United States
    Recruiting
    • Kunal Gogna, MD · Contactkunal@attunehealth.com · 310-652-0010
    • Swamy R Venuturupalli, MD, FACR · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2018 (actual). Primary completion is estimated for Jun 2018, 3 months after the start.

Of 236 non-industry observational studies under Arthritis, Rheumatoid, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 122. This study's planned 3 months is below that.

Counting every sponsor, half of 391 studies reached it within 50 months; a quarter within 25 and three quarters within 113.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 23, 2018
First posted
Mar 8, 2018
StartActual
Mar 16, 2018
Primary completionEst.
Jun 2018
CompletionEst.
Jun 2018
Last update
May 31, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03459274
Collaborators
AppliedVR Inc., Attune Health Research, Inc.
Responsible party
Swamy Venuturupalli (MD, FACR, Cedars-Sinai Medical Center) — Principal investigator
First posted
Mar 8, 2018
Start date
Mar 16, 2018
Primary completion
Jun 2018 (estimated)
Completion
Jun 2018 (estimated)
Last update
May 31, 2018

Study contacts

Kunal Gogna, MD
Contact
kunal@attunehealth.com
310 652 0010 ext. 123
Swamy R Venuturupalli, MD, FACR
principal investigator · Cedars-Sinai Medical Center

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion