Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia

March 1, 2022 updated by: Olaf Blanke, Ecole Polytechnique Fédérale de Lausanne
The present COVID-19 Virtual Reality (COVVR) clinical study is performed to test the hypothesis that an immersive virtual reality (iVR)-based Digital Therapeutics (DTx), would alleviate dyspnea by improving breathing comfort in patients recovering from COVID-19 pneumonia presenting with persistent dyspnea. We will further evaluate participants' perceived awareness of and agency over their breathing movements. Finally, we will track patients' perceived benefits related to the iVR intervention and the feasibility of using COVVR in the clinic or at home.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Persistent dyspnea is the experience of breathlessness that persists despite optimal treatment of the underlying pathophysiology, and results in physical, psychosocial disability for the patient. As observed for SARS-CoV and MERS-CoV patients, a significant portion of COVID-19 patients present with persistent respiratory physiological impairment and persistent breathlessness that may not be addressed with conventional respiratory treatment such as oxygen, bronchodilators, diuretics or non-invasive ventilation.

Previous research on respiration-related feedback in Virtual Reality (VR) has demonstrated strong and replicable effects of VR feedback over one's perceived sense of agency and control over one's virtually embodied respiration. Based on these studies, the VR intervention evaluated here aims to alleviate symptoms of perceived breathlessness.

This within-subject study will compare breathing comfort as well as breathing discomfort, prior, during, and after a VR intervention that provides embodied visual feedback of participants' on-going respiration. Primary outcomes include subjective reports from participants (breathing comfort and breathing discomfort) and the intervention's clinical feasibility. Secondary outcomes include subjective ratings on perceived embodiment and sense of agency, as well as changes in respiration rate and variability.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1205
        • Hôpitaux universitaires de Genève (HUG)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recovering from COVID-19 pneumonia confirmed by RT-PCR for SARS-CoV-2
  • Presented with persistent dyspnea with a self-rated intensity of five or higher (out of ten) on a visual analog dyspnea scale. ( "Do you have difficulty breathing?" "On a scale of 0 to 10, with 0 being no difficulty to breathe and 10 being the worst difficulty to breathe that you can imagine, where do you rank?".) This dyspnea rating will only used as an inclusion criterion and not as an outcome.
  • Being able to give consent
  • Being able to understand and speak French or English

Exclusion Criteria:

  • Any unstable respiratory, neurological, and cardiac conditions
  • Any psychiatric illness
  • Montreal Cognitive Assessment (MoCA) score below 25.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COVVR_A
Participants in the COVVR_A arm complete the synchronous block first, followed by the asynchronous block.
Device: COVVR_Synch

Participants wear a respiration belt (Vernier, Go Direct) that continuously transmits thoracic circumference readings to a mobile phone (Samsung Galaxy S8) in real-time. The mobile device is placed in a headset (Zeiss VR ONEPLUS) and used to create a stereoscopic, immersive scene in Virtual Reality. The data from the respiration belt is used to map the on-going respiration pattern onto a virtual body in the scene in one of two feedback conditions.

COVVR_Synch provided synchronous feedback: participants receive real-time feedback of their respiration.

Device: COVVR_Asynch

Participants wear a respiration belt (Vernier, Go Direct) that continuously transmits thoracic circumference readings to a mobile phone (Samsung Galaxy S8) in real-time. The mobile device is placed in a headset (Zeiss VR ONEPLUS) and used to create a stereoscopic, immersive scene in Virtual Reality. The data from the respiration belt is used to map the on-going respiration pattern onto a virtual body in the scene in one of two feedback conditions.

COVVR_Asynch provided asynchronous feedback: participants receive asynchronous, frequency modulated feedback of their respiration.
Experimental: COVVR_B
Participants in the COVVR_B arm complete the asynchronous block first, followed by the synchronous block.
Device: COVVR_Synch

Participants wear a respiration belt (Vernier, Go Direct) that continuously transmits thoracic circumference readings to a mobile phone (Samsung Galaxy S8) in real-time. The mobile device is placed in a headset (Zeiss VR ONEPLUS) and used to create a stereoscopic, immersive scene in Virtual Reality. The data from the respiration belt is used to map the on-going respiration pattern onto a virtual body in the scene in one of two feedback conditions.

COVVR_Synch provided synchronous feedback: participants receive real-time feedback of their respiration.

Device: COVVR_Asynch

Participants wear a respiration belt (Vernier, Go Direct) that continuously transmits thoracic circumference readings to a mobile phone (Samsung Galaxy S8) in real-time. The mobile device is placed in a headset (Zeiss VR ONEPLUS) and used to create a stereoscopic, immersive scene in Virtual Reality. The data from the respiration belt is used to map the on-going respiration pattern onto a virtual body in the scene in one of two feedback conditions.

COVVR_Asynch provided asynchronous feedback: participants receive asynchronous, frequency modulated feedback of their respiration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy (Breathing Comfort & Discomfort)
Time Frame: through study completion, an average of one year

Efficacy will be evaluated based on subjective feedback by the patients regarding their breathing comfort and discomfort, depending on the intervention.

Subjective ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.

Comfort item: "My breathing was enjoyable" Discomfort item: "I had difficulty breathing"
through study completion, an average of one year
VR Intervention Feasibility
Time Frame: through study completion, an average of one year

Feasibility will be evaluated using a feedback questionnaire, alongside open feedback. Agreement with the questionnaire items indicates better feasibility, acceptance, and perceived outcome.

Ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.

Satisfaction: Did you enjoy the VR experience? Rehabilitation: Would you like to continue using the device during your recovery? Hospital Use: Would you have liked to use this earlier during your stay at the hospital? Home Use: Would you like to continue using the device at home? Respiratory benefit: Do you think the VR feedback improved your breathing? Well-being benefit: Did the VR feedback make you feel better?
through study completion, an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Embodiment
Time Frame: through study completion, an average of one year

Change in subjective ratings about embodiment depending on VR intervention. Two control items are included that are not expected to change between conditions.

Ratings will be measured using a 7-point Likert scale with -3 = Strongly disagree, -2 = Disagree; -1 = Somewhat disagree; 0 = Neither agree nor disagree; 1 = Somewhat agree; 2 = Agree; 3= Strongly agree.

Breathing awareness: It seemed as if the flashing was my respiration Control 1: It seemed as if I had three bodies Breathing agency: I felt as if the virtual body was breathing with me Control 2: I felt as if the virtual body was drifting with the flashing
through study completion, an average of one year
Respiratory Rate
Time Frame: through study completion, an average of one year
Change in respiratory rate depending on VR intervention. Respiratory rate (RR) will be measured in breaths per minute. RR will be assessed with respect to baseline recordings.
through study completion, an average of one year
Respiratory Rate Variability
Time Frame: through study completion, an average of one year

Change in respiratory rate variability depending on VR intervention. Respiratory rate variability (RRV) will be measured using inter-breath intervals (IBI).

RRV will be assessed with respect to baseline recordings.
through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ecole Polytechnique Fédérale de Lausanne

Collaborators

Mindmaze SA

Investigators

  • Principal Investigator: Olaf Blanke, Prof, Ecole Polytechnique Fédérale de Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2020

Primary Completion (Actual)

April 6, 2021

Study Completion (Actual)

April 6, 2021

Study Registration Dates

First Submitted

March 18, 2021

First Submitted That Met QC Criteria

April 13, 2021

First Posted (Actual)

April 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 16, 2022

Last Update Submitted That Met QC Criteria

March 1, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVVR_LNCO2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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