Recruiting

Observational Study

Sponsor:

Florida State University

Code:

NCT05632406

Conditions

Healthy

Overweight and Obesity

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Healthy

Overweight and Obesity

Study ID

NCT05632406

Start date

Oct 25, 2023

Status verified date

Jun, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 45

Healthy Volunteers: Accepted

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

Study Design

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Adults without obesity

body mass index below 30 kg/m\^2

Adults with obesity

body mass index above 30 kg/m\^2

Primary outcome measure

  • Blood pressure during exercise [ Time Frame: Up to one week ]

Central Contacts and Locations

Central contacts

Joseph Watso, PhD

850-644-5260jwatso@fsu.edu

Locations

Florida State University

Recruiting

Tallahassee, Florida, United States, 32306

Contacts

Joseph Watso, PhD

850-644-5260jwatso@fsu.edu

More Information

Sponsor

Florida State University

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Florida State University on 2026-06-26.