Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-26

Study Completion Date

2021-04-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Covid19 Dyspnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Participants perform both conditions. Condition order was randomised across participants using a script prior to data collection.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Caregivers

Participants are naïve to the difference in interventions. Allocation was concealed to the care provider screening participants.

Study Groups

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COVVR_A

Participants in the COVVR\_A arm complete the synchronous block first, followed by the asynchronous block.

Group Type EXPERIMENTAL

COVVR_Synch

Intervention Type DEVICE

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.

COVVR_Asynch

Intervention Type DEVICE

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.

COVVR_B

Participants in the COVVR\_B arm complete the asynchronous block first, followed by the synchronous block.

Group Type EXPERIMENTAL

COVVR_Synch

Intervention Type DEVICE

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.

COVVR_Asynch

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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