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Simple breathing device may help lower blood pressure in obesity

NCT ID NCT05459636

Disease control Sponsor: Florida State University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 2 times

Summary

This study tests whether using a handheld breathing trainer for a few minutes each day can lower blood pressure in adults with obesity. Researchers will compare high-resistance versus very-low-resistance breathing exercises over eight weeks. The goal is to find a time-efficient way to improve heart and lung health.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
inspiratory muscle strength training device
What this could lead to
If it works, this could offer a simple, drug-free way to help manage blood pressure in people with obesity.
What could go wrong
This is a small, early-stage study with only 44 people. It may not show a meaningful effect, and results may not apply to everyone with obesity.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

44 people

The number who actually took part.

Started

Dec 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: \- Body mass index 30 - 40 kg/m2 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) * Pregnant (self-reported and confirmed via urine pregnancy test), lactating (self-reported), or post-menopausal (self-reported) females * Prisoners * 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 dyspnea. * 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 training. * If an individual is suffering from a cold, sinusitis or respiratory tract infection, it is advised that they do not use the POWERbreathe device.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity

Contacts and locations

Locations

  • Florida State University

    Tallahassee, Florida, 32306, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.