Breathing With a Facemask Exercise Performance

Measuring Exercise Performance and Perception With Facemask Resistance

This study will determine the dyspnea response in chronic lung disease volunteers during treadmill walking with and without added inspiratory resistance. This study will also determine the level of dyspnea and exercise sense of effort in individuals walking on a treadmill when elevations occur. Comparisons will be made of a participant's exercise response with and without increased inspiratory resistance. In this study, exercise performance will be analyzed based on physiological and perceptual measures. The participant will undergo two sessions: one session will be a standard exercise walking test without an inspiratory resistance; the other session will be the same standard exercise walking test while breathing with an inspiratory resistance equal to a N95 facemask (R=10-15 cmH2O/L/sec). Performance will be determined by physiological measures. Perception will be determined by scores based on numerical scales and automatically with the forehead Vitality remote monitoring sensor.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Combination product: CereVu Objective Dyspnea Score

• Study Type: Observational
• Enrollment (Actual): 52

Contacts and Locations

Study Locations

• United States
  • California
    • Pleasant Hill, California, United States, 94523
      • John Muir Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing respiratory therapy at John Muir Health which encompasses a variety of pulmonary conditions

Description

Inclusion Criteria:

• Former pulmonary rehabilitation patients that are now participating in maintenance exercise classes
• Males and females with an age range of 18 years or older
• Subjects must be able to walk on treadmill for multiple sessions

Exclusion Criteria:

• The subjects in each experiment will be recruited for a distribution of gender, ethnicity and age

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pulmonary Rehab Patients; Patients who attend respiratory therapy at John Muir Pulmonary Rehab facility	Combination product: CereVu Objective Dyspnea Score; Small forehead wearable and mobile app
Control; Healthy adults, 18+	Combination product: CereVu Objective Dyspnea Score; Small forehead wearable and mobile app

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between dyspnea as measured by the device and reported dyspnea by subjects	2 hours

Collaborators and Investigators

• Sponsor: CereVu Medical, Inc.
• Collaborators: John Muir Health
• Investigators: Study Director: Alireza Akhbardeh, PhD, CereVu Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2022
• Primary Completion (Actual): December 17, 2023
• Study Completion (Actual): September 17, 2024

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Estimated): October 15, 2025
• Last Update Submitted That Met QC Criteria: October 13, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pathological Conditions, Signs and Symptoms; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: CIP5002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No