Breathing & Blood Pressure
Recruiting · NCT05632406 · Observational (researchers observe without assigning treatment) · Lead sponsor: Florida State University
View the official record on ClinicalTrials.gov →What this trial is about
The purpose of this study is to determine the effect of obesity on cardiovascular responses during various breathing maneuvers.
Who can take part
Age range
18 Years to 45 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed across 1 US state.
- Florida State University - Tallahassee, Florida, United States