Breathing & Blood Pressure | NCT05632406

Studies
Breathing & Blood Pressure

NCT05632406

Sponsor

Florida State University

Status

Recruiting

Last Update Posted

Jun 26, 2026Actual

Enrollment

80Estimated

Phase

Not provided

Conditions

Healthy
Overweight and Obesity

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 25, 2023Actual

Primary Completion Date

Jun 30, 2027Estimated

Completion Date

Jun 30, 2027Estimated

First Submitted Date

Nov 14, 2022

First Submission Date that Met QC Criteria

Nov 18, 2022

First Posted Date

Nov 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2026

Last Update Posted Date

Jun 26, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.

Detailed Description

Adults with higher body mass can have trouble breathing during exercise, which could be due to high respiratory muscle workloads. These breathing muscles can require a lot of energy, which takes away energy from other (e.g., leg) muscles. Participating in this study will help us understand how the heart and blood vessels respond during brief exercise and during various breathing maneuvers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Label	Type	Description	Intervention Names
Adults without obesity		body mass index below 30 kg/m^2
Adults with obesity		body mass index above 30 kg/m^2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood pressure during exercise	Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test	Up to one week

Secondary Outcomes

Measure	Description	Time Frame
Blood pressure during respiratory muscle testing	Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)	Up to one week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Body mass index values of ≤40 kg/m^2

Exclusion Criteria:

Not weight stable (<5% change in body mass over the past six months)
Overt cardiovascular, neurological, renal, liver, and/or metabolic illness (e.g., diabetes mellitus)
Current, or history of uncontrolled, Stage 2 hypertension (blood pressure >140 / 90 mmHg; anti-hypertensive medications are permitted)
Diagnosed obstructive sleep apnea
Previous bariatric surgery
Diagnosis or signs (e.g., values below the lower limit of normal) of overt airway disease(s)
Current or recent (regular use within the past 6 months) use of tobacco or nicotine products (e.g., cigarettes, vaping)
Per the POWERbreathe® company:
Patients who have undergone recent abdominal surgery and those with abdominal hernia.
Asthma patients who have a very low symptom perception and suffer from frequent, severe exacerbations or with an abnormally low perception of dyspnoea.
If a patient is suffering from a ruptured eardrum or any other condition of the ear.
Patients with marked elevated left ventricular end-diastolic volume and pressure.
Patients with worsening heart failure signs and symptoms after a respiratory/inspiratory muscle training (IMT) session
If you are suffering from a cold, sinusitis, or respiratory tract infection, we advise that you do not use your POWERbreathe IMT device.
Individuals who are not yet adults (infants, children, teenagers)
Pregnant (self-reported and urine pregnancy test conducted), lactating (self-reported), or post-menopausal (self-reported) females
Prisoners

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Individuals living in, or near, Tallahassee, FL, USA

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Joseph Watso, PhD	Contact	850-644-5260		jwatso@fsu.edu

Name	Affiliation	Role
Joseph Watso, PhD	Florida State University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Florida State University	Recruiting	Tallahassee	Florida	32306	United States

Label	URL
Related Info	View source

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

URL

Not provided

ID	Term
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases
D001835	Body Weight

ID	Term
D050177	Overweight
D009765	Obesity