Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia

Ecole Polytechnique Fédérale de Lausanne

Status: Completed

Conditions: Dyspnea; Covid19

Treatments: Device: COVVR_Synch; Device: COVVR_Asynch

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04844567

COVVR_LNCO2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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26 participants in 2 patient groups

COVVR_A

Experimental group

Description:

Participants in the COVVR_A arm complete the synchronous block first, followed by the asynchronous block.

Treatment:

Device: COVVR_Asynch

Device: COVVR_Synch

COVVR_B

Experimental group

Description:

Participants in the COVVR_B arm complete the asynchronous block first, followed by the synchronous block.

Treatment:

Device: COVVR_Asynch

Device: COVVR_Synch