Virtual Reality Intervention Alleviates Dyspnea in Patients Recovering From COVID Pneumonia

NCT04844567 | Completed DMC

• 1 other identifier: COVVR_LNCO2020
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Covid19; Dyspnea

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Embodiment

  through study completion, an average of one year

• Respiratory Rate

  through study completion, an average of one year

• Respiratory Rate Variability

  through study completion, an average of one year

Study Arms (2)

COVVR_A

EXPERIMENTAL

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

Device: COVVR_Synch; Device: COVVR_Asynch

COVVR_B

EXPERIMENTAL

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

Device: COVVR_Synch; Device: COVVR_Asynch

Interventions

COVVR_Synch 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_A; COVVR_B

COVVR_Asynch 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_A; COVVR_B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Recovering from COVID-19 pneumonia confirmed by RT-PCR for SARS-CoV-2
• Being able to give consent
• Being able to understand and speak French or English

You may not qualify if:

• Any unstable respiratory, neurological, and cardiac conditions
• Any psychiatric illness
• Montreal Cognitive Assessment (MoCA) score below 25.

Sponsors & Collaborators

• Ecole Polytechnique Fédérale de Lausanne: lead
• Mindmaze SA: collaborator

Study Sites (1)

Hopitaux Universitaires de Geneve (HUG)

Geneva, 1205, Switzerland

Location

MeSH Terms

Conditions

COVID-19; Dyspnea

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Olaf Blanke, Prof

  Ecole Polytechnique Fédérale de Lausanne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participants are naïve to the difference in interventions. Allocation was concealed to the care provider screening participants.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

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

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 14, 2021
• Study Start: November 26, 2020
• Primary Completion: April 6, 2021
• Study Completion: April 6, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)