Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT04844567
Status:
COMPLETED
Last Update Posted:
2022-03-16
First Post:
2021-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
Sponsor:
Ecole Polytechnique Fédérale de Lausanne
Organization:
Study Overview
Official Title:
Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: