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Home breathing training shows promise for pompe patients

NCT ID NCT05431127

Symptom relief Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested whether high-dose inspiratory muscle training (IMT) using a handheld device is safe and feasible for people with late-onset Pompe disease. 34 adults with stable Pompe disease did remote breathing exercises. Researchers measured changes in respiratory strength and patient-reported outcomes. The goal was to see if this home-based training could improve breathing and quality of life.

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 training using a Pr02 mobile device
What this could lead to
If successful, this could offer a safe, home-based breathing exercise program to help people with late-onset Pompe disease strengthen their respiratory muscles and improve daily life.
What could go wrong
This was a small, early feasibility study with only 34 participants and no control group. Results may not apply to everyone, and the training might not lead to meaningful long-term improvements.

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

34 people

The number who actually took part.

Started

Jul 2022

Finished

Jan 2025

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 years and older

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: * Age ≥ 18 years * Confirmed diagnosis of LOPD * MIP \>50% of predicted for sex and age * Stable on current Pompe disease treatment regimen \>6 months * Able to follow directions for study participation * Access to computer and smartphone/tablet with reliable internet connection for video visits and sensor-based respiratory technologies Exclusion Criteria: * Presence of medical comorbidities that prevent meaningful study participation (e.g., COPD GOLD III-IV, significant mental illness, dementia) * Use of continuous invasive or non-invasive ventilation while awake * Prior history of gene therapy for LOPD * Inability to give legally effective consent * Inability to read and understand English

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Conditions

The condition(s) this trial relates to.

glycogen storage disease due to acid maltase deficiency, late-onset lysosomal storage disease

As listed by the trial registrant

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

Late-onset Pompe disease Lysosomal disease

Contacts and locations

Locations

  • Duke University Medical Center

    Durham, North Carolina, 27705, United States

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