Covid19 Clinical Trial
Official title:
Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia
Verified date | March 2022 |
Source | Ecole Polytechnique Fédérale de Lausanne |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 26 |
Est. completion date | April 6, 2021 |
Est. primary completion date | April 6, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Hopitaux Universitaires de Geneve (HUG) | Geneva |
Lead Sponsor | Collaborator |
---|---|
Ecole Polytechnique Fédérale de Lausanne | Mindmaze SA |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Efficacy (Breathing Comfort & Discomfort) | 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 | |
Primary | VR Intervention Feasibility | 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 | Embodiment | 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 | |
Secondary | Respiratory Rate | 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 | |
Secondary | Respiratory Rate Variability | 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 |
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