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Pompe disease: new study probes hidden nerve damage behind breathing problems

NCT ID NCT07664930

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study aims to better understand how Pompe disease affects the nerves and muscles involved in breathing. Researchers will analyze nerve conduction and diaphragm activity in 20 adults with Pompe disease or unexplained respiratory failure. The goal is to identify patterns that could serve as early markers of respiratory involvement.

What this could mean

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

What this could lead to
If successful, this study could help identify early markers of respiratory problems in Pompe disease, potentially guiding earlier interventions.
What could go wrong
This is a small observational study (20 participants) that does not test any treatment. It may not lead to immediate clinical changes.

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.

Participants

About 20 people

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

Started

Mar 2026

Expected to finish

Feb 2029

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.

Who is studied

Approximately 20 adult patients with genetically confirmed Pompe disease are expected to be prospectively included. In addition, a retrospective review of approximately 150 previously performed phrenic nerve conduction studies and diaphragm electromyography examinations in patients with unexplained respiratory failure will be conducted. The prospective enrollment refers exclusively to newly evaluated Pompe disease patients, while the retrospective component is based on existing clinical records and neurophysiological data

Ages

18 years and older

Sex

Anyone

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. For the prospective cohort: * Genetically confirmed diagnosis of Pompe disease. * Ability to undergo routine neurophysiological and respiratory assessments. * Written informed consent provided. For the retrospective cohort: * History of restrictive respiratory failure or unexplained hypoventilation. * Availability of previous phrenic nerve conduction studies and/or diaphragm electromyography performed as part of routine clinical evaluation. Exclusion Criteria: \- Age \< 18 years. For the prospective cohort: * Conditions preventing completion of neurophysiological assessments (e.g., inability to maintain required positioning or relevant clinical contraindications). * Known primary phrenic nerve injury (e.g., postsurgical phrenic palsy or documented traumatic phrenic neuropathy). * Presence of other neuromuscular disorders potentially confounding data interpretation. * Refusal or inability to provide informed consent. For the retrospective cohort: * Incomplete or technically non-interpretable neurophysiological examinations. * Previously established respiratory or neuromuscular diagnoses fully explaining respiratory impairment. * Cases requiring additional clinical information for study purposes when patient consent for contact or data completion cannot be obtained.

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Conditions

The condition(s) this trial relates to.

glycogen storage disease II Glycogen Storage Disease Type II

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Translational Neurophysiology

    RECRUITING

    Pavia, 27100, Italy

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