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Breathing With a Facemask Exercise Performance - Trial NCT05633017

Access comprehensive clinical trial information for NCT05633017 through Pure Global AI's free database. This phase not specified trial is sponsored by CereVu Medical, Inc. and is currently Not yet recruiting. The study focuses on Pulmonary Disease, Chronic Obstructive. Target enrollment is 100 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT05633017
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combination product
Trial Details
ClinicalTrials.gov โ€ข NCT05633017
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Breathing With a Facemask Exercise Performance
Measuring Exercise Performance and Perception With Facemask Resistance

Study Focus

CereVu Objective Dyspnea Score

Observational

combination product

Sponsor & Location

CereVu Medical, Inc.

Timeline & Enrollment

N/A

Nov 29, 2022

Dec 31, 2023

100 participants

Primary Outcome

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

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.

ICD-10 Classifications

Chronic obstructive pulmonary disease, unspecified
Other chronic obstructive pulmonary disease
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Chronic obstructive pulmonary disease with acute lower respiratory infection

Data Source

ClinicalTrials.gov

NCT05633017

Non-Device Trial