Breathing With a Facemask Exercise Performance

NCT05633017 | Completed

• 1 other identifier: CIP5002
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Correlation between dyspnea as measured by the device and reported dyspnea by subjects

  2 hours

Study Arms (2)

Pulmonary Rehab Patients

Patients who attend respiratory therapy at John Muir Pulmonary Rehab facility

Combination Product: CereVu Objective Dyspnea Score

Control

Healthy adults, 18+

Combination Product: CereVu Objective Dyspnea Score

Interventions

CereVu Objective Dyspnea Score COMBINATION_PRODUCT

Small forehead wearable and mobile app

Control; Pulmonary Rehab Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CereVu Medical, Inc.: lead
• John Muir Health: collaborator

Study Sites (1)

John Muir Health

Pleasant Hill, California, 94523, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alireza Akhbardeh, PhD

  CereVu Medical

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: December 1, 2022
• Study Start: November 29, 2022
• Primary Completion: December 17, 2023
• Study Completion: September 17, 2024
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)