Pulmonary Disease, Chronic ObstructiveNCT05633017
Breathing With a Facemask Exercise Performance
An observational study of Pulmonary Disease, Chronic Obstructive, run by CereVu Medical, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- CereVu Objective Dyspnea Score
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Nov 2022to 17 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing respiratory therapy at John Muir Health which encompasses a variety of pulmonary conditions
Who may be able to join
- 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
Who cannot join
- The subjects in each experiment will be recruited for a distribution of gender, ethnicity and age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- CereVu Objective Dyspnea Score
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CereVu Objective Dyspnea ScoreCombination product
Small forehead wearable and mobile app
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Rehab Patients | Patients who attend respiratory therapy at John Muir Pulmonary Rehab facility Receives: Combination Product: CereVu Objective Dyspnea Score | |
| Control | Healthy adults, 18+ Receives: Combination Product: CereVu Objective Dyspnea Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between dyspnea as measured by the device and reported dyspnea by subjects
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start29 Nov 2022
- Primary completion17 Dec 2023
- Study completion17 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- CereVu Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- John Muir Health
- Responsible party
- Sponsor
- Investigators
- Alireza Akhbardeh, PhD, Study director, CereVu Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633017
- Sponsor's protocol ID
- CIP5002
- Status last verified
- Oct 2025
- First submitted
- 21 Nov 2022
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Exercise Performance and Perception With Facemask Resistance
- ClinicalTrials.gov ID
- NCT05633017
- Acronym / sponsor ID
- CIP5002
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- CereVu Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- John Muir Health
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 17 Dec 2023 (actual)
- Study completion
- 17 Sep 2024 (actual)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehab Patients | – | Combination Product: CereVu Objective Dyspnea ScorePatients who attend respiratory therapy at John Muir Pulmonary Rehab facility |
| Control | – | Combination Product: CereVu Objective Dyspnea ScoreHealthy adults, 18+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing respiratory therapy at John Muir Health which encompasses a variety of pulmonary conditions
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- The subjects in each experiment will be recruited for a distribution of gender, ethnicity and age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CereVu Objective Dyspnea ScoreSmall forehead wearable and mobile app | Combination product | Control, Pulmonary Rehab Patients |
Primary outcome
Correlation between dyspnea as measured by the device and reported dyspnea by subjects
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alireza Akhbardeh, PhD study director
CereVu Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Disease, Chronic Obstructive, run by CereVu Medical, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between dyspnea as measured by the device and reported dyspnea by subjects (time frame: 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2025.