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Vest vibrations may cut lung infections in ALS patients

NCT ID NCT07656714

Symptom relief Sponsor: Hospital Universitario Virgen Macarena 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested whether adding a vibrating chest vest to a standard cough-assist machine could reduce lung infections and hospital stays in people with ALS who use breathing support. Fourteen patients were randomly assigned to use either the vest plus cough assist or the cough assist alone for three months. The goal was to see if the vest helps clear mucus better and lowers the need for antibiotics or hospital visits.

What this could mean

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

Active substance
High-frequency chest wall oscillation (HFCWO) vest and mechanical cough assist device
What this could lead to
If it works, this could offer a way to reduce lung infections and hospital visits for people with ALS who use breathing support.
What could go wrong
This was a very small pilot study with only 14 participants, so results may not apply to everyone. The devices are already available, so the main question is whether adding the vest is worth the extra effort.

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

14 people

The number who actually took part.

Started

Apr 2021

Finished

Apr 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: 1. Confirmed diagnosis of ALS according to the Revised El Escorial criteria 2. Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena 3. Age between 18 and 90 years 4. Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted 5. Ability to travel to the Neurolab centre exclusion criteria: 1. Need for invasive mechanical ventilation 2. Total dependence on non-invasive ventilation (NIV) 3. Severe bulbar involvement 4. Cognitive impairment 5. Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma

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Conditions

The condition(s) this trial relates to.

amyotrophic lateral sclerosis respiratory tract infectious disorder

As listed by the trial registrant

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

Amyotrophic lateral sclerosis Respiratory infection

Contacts and locations

Locations

  • Hospital Universitario Virgen Macarena

    Seville, Andalusia, 41009, Spain

More trials for these conditions

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