Clinical trial NCT04844567: Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
Official title: Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Covid19
Dyspnea
Lead sponsor: Ecole Polytechnique Fédérale de Lausanne
Sponsor class: OTHER
Collaborators: name: Mindmaze SA
First posted: 2021-04-14
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants perform both conditions. Condition order was randomised across participants using a script prior to data collection.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy (Breathing Comfort & Discomfort)
timeFrame: through study completion, an average of one year
measure: VR Intervention Feasibility
timeFrame: through study completion, an average of one year
Secondary outcomes:
measure: Embodiment
timeFrame: through study completion, an average of one year
measure: Respiratory Rate
timeFrame: through study completion, an average of one year
measure: Respiratory Rate Variability
timeFrame: through study completion, an average of one year
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Hopitaux Universitaires de Geneve (HUG)
Study officials:
affiliation: Ecole Polytechnique Fédérale de Lausanne
name: Olaf Blanke, Prof
role: PRINCIPAL_INVESTIGATOR
References: