Comparing Nose & Mouth Breathing During Exercise
Primary Purpose
Healthy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nose-only breathing
Mouth-only breathing
Sponsored by
About this trial
This is an interventional basic science trial for Healthy
Eligibility Criteria
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)
Sites / Locations
- Florida State University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Nose-only breathing
Mouth-only breathing
Arm Description
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Outcomes
Primary Outcome Measures
Blood pressure during exercise between study arms
Systolic and diastolic blood pressure will be measured in the laboratory at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Heart rate during exercise between study arms
Heart rate will be measured in the laboratory at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Secondary Outcome Measures
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 at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
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 at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Full Information
NCT ID
NCT05702047
First Posted
January 19, 2023
Last Updated
March 28, 2023
Sponsor
Florida State University
1. Study Identification
Unique Protocol Identification Number
NCT05702047
Brief Title
Comparing Nose & Mouth Breathing During Exercise
Official Title
Comparing Nose & Mouth Breathing During Exercise
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
March 23, 2023 (Actual)
Study Completion Date
March 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nose-only breathing
Arm Type
Active Comparator
Arm Description
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Arm Title
Mouth-only breathing
Arm Type
Active Comparator
Arm Description
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Intervention Type
Behavioral
Intervention Name(s)
Nose-only breathing
Intervention Description
Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
Intervention Type
Behavioral
Intervention Name(s)
Mouth-only breathing
Intervention Description
Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Primary Outcome Measure Information:
Title
Blood pressure during exercise between study arms
Description
Systolic and diastolic blood pressure will be measured in the laboratory at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Time Frame
Up to one day
Title
Heart rate during exercise between study arms
Description
Heart rate will be measured in the laboratory at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Time Frame
Up to one day
Secondary Outcome Measure Information:
Title
Rating of perceived exertion during exercise between study arms
Description
Participants will report their rating of perceived exertion (numerical scores of 6-20, with 20 being the greatest exertion) based on a validated scale at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Time Frame
Up to one day
Title
Rating of perceived breathlessness during exercise between study arms
Description
Participants will report their rating of perceived breathlessness (numerical scores of 0-10, with 10 being the greatest breathlessness) based on a validated scale at rest and during submaximal exercise with nose-only breathing and mouth-only breathing.
Time Frame
Up to one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Watso, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Links:
URL
https://caplaboratory.com/
Description
Related Info
Learn more about this trial
Comparing Nose & Mouth Breathing During Exercise
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