An interventional study of Nose-only breathing and Mouth-only breathing in Healthy, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-15.
Sponsored by Florida State University · Not applicable, Interventional, and Basic science
The purpose of this study is to compare physiological responses in cardiovascular variables between nose and mouth breathing at rest and during exercise.
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.
Florida State University is the lead sponsor of 245 studies on the registry; 46 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.
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Exclusion Criteria:
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Behavioral: Nose-only breathing
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Behavioral: Mouth-only breathing
Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
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.
Time frame: 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.
Time frame: Up to one day
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.
Time frame: 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.
Time frame: Up to one day
| Milestone | Mouth Breathing Then Nose Breathing | Nose Breathing Then Mouth Breathing |
|---|---|---|
| Started | 10 | 10 |
| Completed | 10 | 10 |
| Not completed | 0 | 0 |
Systolic blood pressure will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
| mmHg | Nose-only Breathing | Mouth-only Breathing |
|---|---|---|
| Blood Pressure During Exercise Between Study Arms | 142 ± 14 | 146 ± 12 |
Heart rate will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
| beats per minute | Nose-only Breathing | Mouth-only Breathing |
|---|---|---|
| Heart Rate During Exercise Between Study Arms | 130 ± 20 | 133 ± 22 |
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.
| units on a scale | Nose-only Breathing | Mouth-only Breathing |
|---|---|---|
| Rating of Perceived Exertion During Exercise Between Study Arms | 13 ± 3 | 12 ± 2 |
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.
| units on a scale | Nose-only Breathing | Mouth-only Breathing |
|---|---|---|
| Rating of Perceived Breathlessness During Exercise Between Study Arms | 2 (1.25 to 2.75) | 3 (1.85 to 4.15) |
Collected over Up to one day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nose-only Breathing | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Mouth-only Breathing | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Categorical(Participants) | All Participants |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 20 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 13 |
| Male | 7 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 16 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 19 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | All Participants |
|---|---|
| United States | 20 |
| Body mass index(kilograms per meters squared) | All Participants |
|---|---|
| Mean | 23 ± 2 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: One year after completion of the trial, indefinitely
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.
This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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