Breathing & Blood Pressure
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 Start (Actual) 25 October 2023
🗓️ Primary Completion (Estimated) 30 June 2027
✅ Study Completion (Estimated) 30 June 2027
👥 Enrollment (Estimated) 80
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Tallahassee, Florida, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 20 Years to 45 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 14 November 2022
  • First Submitted that Met QC Criteria 18 November 2022
  • First Posted 30 November 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 November 2023
  • Last Update Posted 8 November 2023
  • Last Verified November 2023