Breathing With a Facemask Exercise Performance

NCT ID: NCT05633017

Last Updated: 2025-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-29

Study Completion Date

2024-09-17

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pulmonary Rehab Patients

Patients who attend respiratory therapy at John Muir Pulmonary Rehab facility

CereVu Objective Dyspnea Score

Intervention Type COMBINATION_PRODUCT

Small forehead wearable and mobile app

Control

Healthy adults, 18+

CereVu Objective Dyspnea Score

Intervention Type COMBINATION_PRODUCT

Small forehead wearable and mobile app

Interventions

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CereVu Objective Dyspnea Score

Small forehead wearable and mobile app

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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John Muir Health

OTHER

Sponsor Role collaborator

CereVu Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alireza Akhbardeh, PhD

Role: STUDY_DIRECTOR

CereVu Medical

Locations

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John Muir Health

Pleasant Hill, California, United States

Site Status

Countries

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United States

Other Identifiers

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CIP5002

Identifier Type: -

Identifier Source: org_study_id

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