NCT05702047

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 19, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 27, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2023

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 15, 2024

Completed
Last Updated

November 15, 2024

Status Verified

September 1, 2024

Enrollment Period

2 months

First QC Date

January 19, 2023

Results QC Date

November 8, 2023

Last Update Submit

September 11, 2024

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Up to one day

Secondary Outcomes (2)

  • Rating of Perceived Exertion During Exercise Between Study Arms

    Up to one day

  • Rating of Perceived Breathlessness During Exercise Between Study Arms

    Up to one day

Study Arms (2)

Nose-only breathing

ACTIVE COMPARATOR

Participants will be instructed to breathe only through their nose (mouth closed) during rest and submaximal exercise.

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.

Behavioral: Mouth-only breathing

Interventions

Nose-only breathingBEHAVIORAL

Participants will breathe only through their nose (mouth closed) during rest and submaximal exercise.

Nose-only breathing
Mouth-only breathingBEHAVIORAL

Participants will breathe only through their mouth (nose clips prevent nose breathing) during rest and submaximal exercise.

Mouth-only breathing

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Body mass index: ≤30 kg/m2
  • Resting Blood pressure: ≤140/90 mmHg

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306, United States

Location

Related Links

Results Point of Contact

Title
Director, Cardiovascular and Applied Physiology Laboratory
Organization
Florida State University
jwatso@fsu.edu
8506441828

Study Officials

  • Joseph Watso, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 19, 2023

First Posted

January 27, 2023

Study Start

January 13, 2023

Primary Completion

March 23, 2023

Study Completion

March 23, 2023

Last Updated

November 15, 2024

Results First Posted

November 15, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share

Data with all HIPAA identifiers removed may be shared in future collaborative efforts pending appropriate data and/or material transfer agreement approvals.

Shared Documents
STUDY PROTOCOL, SAP, ICF
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.

Locations

US(1)