- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05702047
Comparing Nose & Mouth Breathing During Exercise
September 11, 2024 updated by: Joseph Watso, Florida State University
The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 30 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Body mass index: ≤30 kg/m2
- Resting Blood pressure: ≤140/90 mmHg
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Nose-only breathing
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
|
Active Comparator: Mouth-only breathing
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Up to one day
|
|
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.
|
Up to one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rating of Perceived Exertion During Exercise Between Study Arms
Time Frame: Up to one day
|
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.
|
Up to one day
|
|
Rating of Perceived Breathlessness During Exercise Between Study Arms
Time Frame: Up to one day
|
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.
|
Up to one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joseph Watso, PhD, Florida State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2023
Primary Completion (Actual)
March 23, 2023
Study Completion (Actual)
March 23, 2023
Study Registration Dates
First Submitted
January 19, 2023
First Submitted That Met QC Criteria
January 19, 2023
First Posted (Actual)
January 27, 2023
Study Record Updates
Last Update Posted (Actual)
November 15, 2024
Last Update Submitted That Met QC Criteria
September 11, 2024
Last Verified
September 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003661
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
IPD Sharing Time Frame
One year after completion of the trial, indefinitely
IPD Sharing Access Criteria
A formal plan identifying the intended use of the data and proper completion of appropriate data and/or material transfer agreement approvals with the study PI and their institution.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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