Trial Outcomes & Findings for Comparing Nose & Mouth Breathing During Exercise (NCT NCT05702047)
NCT ID: NCT05702047
Last Updated: 2024-11-15
Results Overview
Systolic blood pressure will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
20 participants
Primary outcome timeframe
Up to one day
Results posted on
2024-11-15
Participant Flow
Participant milestones
| Measure |
Mouth Breathing Then Nose Breathing
1\. Participants will be instructed to breathe only through their mouth (nose clips on) during rest and submaximal exercise. 2. Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Nose Breathing Then Mouth Breathing
1\. Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise. 2. Participants will be instructed to breathe only through their mouth (nose clips on) during rest and submaximal exercise.
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparing Nose & Mouth Breathing During Exercise
Baseline characteristics by cohort
| Measure |
All Participants
n=20 Participants
These numbers are for all participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
20 Participants
n=99 Participants
|
|
Body mass index
|
23 kilograms per meters squared
STANDARD_DEVIATION 2 • n=99 Participants
|
PRIMARY outcome
Timeframe: Up to one dayPopulation: 17 participants completed both arms with this variable measured
Systolic blood pressure will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Outcome measures
| Measure |
Nose-only Breathing
n=17 Participants
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Nose-only breathing: Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Mouth-only Breathing
n=17 Participants
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Mouth-only breathing: Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
|---|---|---|
|
Blood Pressure During Exercise Between Study Arms
|
142 mmHg
Standard Deviation 14
|
146 mmHg
Standard Deviation 12
|
PRIMARY outcome
Timeframe: Up to one dayPopulation: 18 participants completed both arms with this variable measured
Heart rate will be measured in the laboratory during submaximal exercise with nose-only breathing and mouth-only breathing.
Outcome measures
| Measure |
Nose-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Nose-only breathing: Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Mouth-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Mouth-only breathing: Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
|---|---|---|
|
Heart Rate During Exercise Between Study Arms
|
130 beats per minute
Standard Deviation 20
|
133 beats per minute
Standard Deviation 22
|
SECONDARY outcome
Timeframe: Up to one dayPopulation: 18 participants completed both arms with this variable measured
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.
Outcome measures
| Measure |
Nose-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Nose-only breathing: Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Mouth-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Mouth-only breathing: Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
|---|---|---|
|
Rating of Perceived Exertion During Exercise Between Study Arms
|
13 units on a scale
Standard Deviation 3
|
12 units on a scale
Standard Deviation 2
|
SECONDARY outcome
Timeframe: Up to one dayPopulation: 18 participants completed both arms with this variable measured
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.
Outcome measures
| Measure |
Nose-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.
Nose-only breathing: Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.
|
Mouth-only Breathing
n=18 Participants
Participants will be instructed to breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
Mouth-only breathing: Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.
|
|---|---|---|
|
Rating of Perceived Breathlessness During Exercise Between Study Arms
|
2 units on a scale
Interval 1.25 to 2.75
|
3 units on a scale
Interval 1.85 to 4.15
|
Adverse Events
Nose-only Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mouth-only Breathing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director, Cardiovascular and Applied Physiology Laboratory
Florida State University
Phone: 8506441828
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place