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Recruiting

NCT Number: NCT05632406

Breathing & Blood Pressure

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

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

Location status: Recruiting

Location contact

Joseph Watso, PhD

CONTACT

[email protected]

850-644-5260

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood pressure during exercise

    Time frame: Up to one week

    Systolic and diastolic blood pressure measured in the laboratory at rest and during an incremental aerobic exercise test

Secondary outcomes

  1. Blood pressure during respiratory muscle testing

    Time frame: Up to one week

    Systolic and diastolic blood pressure measured in the laboratory at rest and during a respiratory muscle exercise test (eucapnic voluntary hyperpnea)

Study contacts

Contact information is provided by the study sponsor or research team.

Joseph Watso, PhD

CONTACT

[email protected]

850-644-5260

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 30, 2022
Registry last updated
Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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