HealthyNCT05702047
Comparing Nose & Mouth Breathing During Exercise
A study testing Nose-only breathing and Mouth-only breathing in people with Healthy, run by Florida State University at 1 site in United States.
Trial summary
The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nose-only breathing and Mouth-only breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jan 2023to 23 Mar 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index: ≤30 kg/m2
- Resting Blood pressure: ≤140/90 mmHg
Who cannot join
- Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health condition
- Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University
Tallahassee, Florida, 32306
About this study
The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.
Read the detailed description
Breathing patterns can affect the cardiovascular system. Little is known about how nose versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at rest and during exercise. It has been suggested that breathing through the nose can cause calmness and lower blood pressure. However, research is needed to examine the extent to which breathing through the nose affects cardiovascular variables at rest and during exercise. Therefore, we will compare cardiovascular variables between nose-only and mouth-only breathing. The rate of breathing will be fixed (using an audible metronome) for both breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e., no breathing cues) breathing rate.
- Conditions
- Healthy
- Being tested
- Nose-only breathing, Mouth-only breathing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nose-only breathingBehavioural
Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
Mouth-only breathingBehavioural
Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
| Study group | Role | What they receive |
|---|---|---|
| Nose-only breathing | Active comparator | Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise. Receives: Behavioral: Nose-only breathing |
| Mouth-only breathing | Active comparator | Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise. Receives: Behavioral: Mouth-only breathing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure During Exercise Between Study Arms
Systolic blood pressure will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Measured: Up to one day
Heart Rate During Exercise Between Study Arms
Heart rate will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Measured: Up to one day
Secondary outcomes (2)
Rating of Perceived Exertion During Exercise Between Study Arms
Participants will report their rating of perceived exertion (numerical scores of 6-20, with 20 being the greatest exertion) based on a validated scale during submaximal exercise with nose-only breathing and mouth-only breathing.
Measured: Up to one day
Rating of Perceived Breathlessness During Exercise Between Study Arms
Participants will report their rating of perceived breathlessness (numerical scores of 0-10, with 10 being the greatest breathlessness) based on a validated scale during submaximal exercise with nose-only breathing and mouth-only breathing.
Measured: Up to one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start13 Jan 2023
- Primary completion23 Mar 2023
- Study completion23 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Watso, Florida State University
- Investigators
- Joseph Watso, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05702047
- Sponsor's protocol ID
- STUDY00003661
- Status last verified
- Sep 2024
- First submitted
- 19 Jan 2023
- Last updated
- 15 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Nose & Mouth Breathing During Exercise
- ClinicalTrials.gov ID
- NCT05702047
- Acronym / sponsor ID
- STUDY00003661
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 13 Jan 2023 (actual)
- Primary completion
- 23 Mar 2023 (actual)
- Study completion
- 23 Mar 2023 (actual)
- First posted
- 27 Jan 2023 (actual)
- Results
- Posted 15 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.
Detailed description
Breathing patterns can affect the cardiovascular system. Little is known about how nose versus mouth breathing affects cardiovascular variables (blood pressure, heart rate, etc.) at rest and during exercise. It has been suggested that breathing through the nose can cause calmness and lower blood pressure. However, research is needed to examine the extent to which breathing through the nose affects cardiovascular variables at rest and during exercise. Therefore, we will compare cardiovascular variables between nose-only and mouth-only breathing. The rate of breathing will be fixed (using an audible metronome) for both breathing conditions (nose-only vs mouth-only) based on an individual's free breathing (i.e., no breathing cues) breathing rate.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nose-only breathing | Active comparator | Behavioral: Nose-only breathingParticipants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise. |
| Mouth-only breathing | Active comparator | Behavioral: Mouth-only breathingParticipants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Body mass index: ≤30 kg/m2
- Resting Blood pressure: ≤140/90 mmHg
Key exclusion criteria (2 listed)
- Overt cardiovascular (e.g., diagnosed hypertension), respiratory, neurological, renal, liver, and/or metabolic health condition
- Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes)
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 |
|---|---|---|
| Nose-only breathingParticipants will breathe only through their nose (mouth closed) during rest and submaximal exercise. | Behavioural | Nose-only breathing |
| Mouth-only breathingParticipants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise. | Behavioural | Mouth-only breathing |
Primary outcome
Blood Pressure During Exercise Between Study Arms
Time frame: Up to one day
Systolic blood pressure will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Heart Rate During Exercise Between Study Arms
Time frame: Up to one day
Heart rate will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
2 secondary outcomes
Rating of Perceived Exertion During Exercise Between Study Arms
Time frame: Up to one day
Rating of Perceived Breathlessness During Exercise Between Study Arms
Time frame: Up to one day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
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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.
Joseph Watso, PhD principal investigator
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nose-only breathing and Mouth-only breathing in people with Healthy, run by Florida State University 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 2 inclusion and 2 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 Nov 2024. 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?
Yes. Results are posted in the registry (first posted 15 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Blood Pressure During Exercise Between Study Arms (time frame: Up to one day). The study lists 2 primary outcomes in all. 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 Nov 2024; AzTrials last refreshed its copy on 31 Oct 2026.