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Could a digital device help COPD patients breathe easier?

NCT ID NCT07346261

Symptom relief Sponsor: Cairo 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 This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a digital breathing trainer that helps COPD patients strengthen their breathing muscles through forceful inhales and exhales. Sixty participants with moderate to severe COPD will use the device twice daily for eight weeks, alongside standard rehab. Researchers will measure changes in lung function and how far patients can walk in six minutes.

What this could mean

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

Active substance
Digital Sonmol Respiratory Muscle Trainer (device)
What this could lead to
If it works, this could offer a convenient home-based way to improve breathing and exercise ability in people with COPD.
What could go wrong
This is a small, early-stage trial with only 60 participants, and the device is not yet proven to be effective. Results may not apply to all COPD patients.

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

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Apr 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

50 to 60 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. Clinical diagnosis of chronic obstructive pulmonary disease (COPD), moderate to severe (GOLD stage II-IV) 2. FEV₁ \> 80% of predicted. 3. Age 50-65 years. 4. Able to perform high-intensity respiratory muscle training (MIP and MEP ≥ device threshold). 5. Clinically stable with no acute exacerbations. Exclusion Criteria: 1. Severe comorbidities (e.g., coronary heart disease, arterial aneurysm, severe hepatic or renal dysfunction, uncontrolled hypertension). 2. Unstable medical conditions or other respiratory diseases that could cause or contribute to breathlessness (e.g., asthma, pneumonia, bronchiectasis, tuberculosis, interstitial lung disease). 3. Mental illness, deafness, limb activity disorder, or any condition causing inability to cooperate with procedures. 4. Cognitive impairment or psychiatric illness that affects cooperation. 5. Participation in another clinical trial or intervention within the last 3 months. 6. Current use of any other respiratory muscle training device or app.

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Conditions

The condition(s) this trial relates to.

chronic obstructive pulmonary disease COPD, severe early onset

As listed by the trial registrant

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

COPD (chronic obstructive pulmonary disease) Hirmt (high intensity respiratory muscle training)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

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