Amyotrophic Lateral SclerosisNCT07656714
HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial
A study testing High-frequency chest wall oscillation (HFCWO) vest and Mechanical cough assist in people with Amyotrophic Lateral Sclerosis and Respiratory Infection, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
Trial summary
This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Respiratory Infection
- What is being tested?
- High-frequency chest wall oscillation (HFCWO) vest and Mechanical cough assist
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSpain
- Study dates
- 15 Apr 2021to 27 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of ALS according to the Revised El Escorial criteria
- Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena
- Age between 18 and 90 years
- Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted
- Ability to travel to the Neurolab centre
Who cannot join
- Need for invasive mechanical ventilation
- Total dependence on non-invasive ventilation (NIV)
- Severe bulbar involvement
- Cognitive impairment
- Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of High-frequency Chest Wall Oscillation (HFCWO) Via Chest Vest Combined With Mechanical Cough Assist Versus Mechanical Cough Assist Alone on Respiratory Infections and Hospital Admissions in Patients With Amyotrophic Lateral Sclerosis Receiving Non-invasive Ventilation: a Randomised Single-blind Pilot Trial
This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation.
Read the detailed description
Patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation (NIV) at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena (Seville, Spain) were randomised to two parallel groups. The experimental group received high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II/CC20) combined with mechanical cough assist, while the control group received mechanical cough assist alone. The intervention period lasted 3 months, followed by 3 months of follow-up. Primary outcomes included respiratory infections and hospital admissions. Secondary outcomes included respiratory function, quality of life, sleep quality, and secretion clearance capacity. The study was approved by the Ethics Committee of Hospital Universitario Virgen Macarena - Virgen del Rocío (code 2020-01) and sponsored by FISEVI (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía).
- Being tested
- High-frequency chest wall oscillation (HFCWO) vest, Mechanical cough assist
- Keywords
- Amyotrophic Lateral Sclerosis High-frequency chest wall oscillation Mechanical cough assist Respiratory infections Secretion clearance ALS
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-frequency chest wall oscillation (HFCWO) vestDevice
Also called ComfortCough II , CC20
Chest wall oscillation vest delivering high-frequency vibrations to mobilise secretions, used in addition to mechanical cough assist device during the 3-month intervention period.
Mechanical cough assistDevice
Also called Cough assist device
Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| arm label Experimental: HFCWO plus mechanical cough assist | Experimental | Patients received high-frequency chest wall oscillation via chest vest (ComfortCough II) combined with mechanical cough assist for 3 months followed by 3 months follow-up. Receives: Device: High-frequency chest wall oscillation (HFCWO) vest; Device: Mechanical cough assist |
| Control: Mechanical cough assist alone | Active comparator | Patients received mechanical cough assist alone for 3 months followed by 3 months follow-up. Receives: Device: Mechanical cough assist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of respiratory infections
Number of respiratory infections requiring antibiotic treatment during the study period
Measured: 6 months (3 months intervention plus 3 months follow-up)
Secondary outcomes (1)
Number of hospital admissions
Number of hospital admissions due to respiratory causes during the study period
Measured: 6 months (3 months intervention plus 3 months follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2026
- Study start15 Apr 2021
- Primary completion2 Nov 2023
- Study completion27 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two parallel arms: experimental group receiving HFCWO chest vest combined with mechanical cough assist versus control group receiving mechanical cough assist alone. Randomised single-blind design.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Virgen Macarena
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Concepcion Romero Muñoz, Principal investigator, Hospital Universitario Virgen Macarena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07656714
- Sponsor's protocol ID
- Tosedores 1
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of High-frequency Chest Wall Oscillation (HFCWO) Via Chest Vest Combined With Mechanical Cough Assist Versus Mechanical Cough Assist Alone on Respiratory Infections and Hospital Admissions in Patients With Amyotrophic Lateral Sclerosis Receiving Non-invasive Ventilation: a Randomised Single-blind Pilot Trial
- ClinicalTrials.gov ID
- NCT07656714
- Acronym / sponsor ID
- Tosedores 1
- Keywords
- Amyotrophic Lateral Sclerosis High-frequency chest wall oscillation Mechanical cough assist Respiratory infections Secretion clearance ALS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Hospital Universitario Virgen MacarenaUniversity, hospital or other
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 27 Apr 2025 (actual)
- First posted
- 18 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation.
Detailed description
Patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation (NIV) at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena (Seville, Spain) were randomised to two parallel groups. The experimental group received high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II/CC20) combined with mechanical cough assist, while the control group received mechanical cough assist alone. The intervention period lasted 3 months, followed by 3 months of follow-up. Primary outcomes included respiratory infections and hospital admissions. Secondary outcomes included respiratory function, quality of life, sleep quality, and secretion clearance capacity. The study was approved by the Ethics Committee of Hospital Universitario Virgen Macarena - Virgen del Rocío (code 2020-01) and sponsored by FISEVI (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Two parallel arms: experimental group receiving HFCWO chest vest combined with mechanical cough assist versus control group receiving mechanical cough assist alone. Randomised single-blind design.
| Arm | Type | Receives |
|---|---|---|
| arm label Experimental: HFCWO plus mechanical cough assist | Experimental | Device: High-frequency chest wall oscillation (HFCWO) vest, Device: Mechanical cough assistPatients received high-frequency chest wall oscillation via chest vest (ComfortCough II) combined with mechanical cough assist for 3 months followed by 3 months follow-up. |
| Control: Mechanical cough assist alone | Active comparator | Device: Mechanical cough assistPatients received mechanical cough assist alone for 3 months followed by 3 months follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed diagnosis of ALS according to the Revised El Escorial criteria
- Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena
- Age between 18 and 90 years
- Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted
- Ability to travel to the Neurolab centre
Key exclusion criteria (5 listed)
- Need for invasive mechanical ventilation
- Total dependence on non-invasive ventilation (NIV)
- Severe bulbar involvement
- Cognitive impairment
- Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-frequency chest wall oscillation (HFCWO) vestAlso: ComfortCough II , CC20Chest wall oscillation vest delivering high-frequency vibrations to mobilise secretions, used in addition to mechanical cough assist device during the 3-month intervention period. | Device | arm label Experimental: HFCWO plus mechanical cough assist |
| Mechanical cough assistAlso: Cough assist deviceMechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period. | Device | Control: Mechanical cough assist alone, arm label Experimental: HFCWO plus mechanical cough assist |
Primary outcome
Number of respiratory infections
Time frame: 6 months (3 months intervention plus 3 months follow-up)
Number of respiratory infections requiring antibiotic treatment during the study period
1 secondary outcome
Number of hospital admissions
Time frame: 6 months (3 months intervention plus 3 months follow-up)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Concepcion Romero Muñoz principal investigator
Hospital Universitario Virgen Macarena
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-frequency chest wall oscillation (HFCWO) vest and Mechanical cough assist in people with Amyotrophic Lateral Sclerosis and Respiratory Infection, run by Hospital Universitario Virgen Macarena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of respiratory infections (time frame: 6 months (3 months intervention plus 3 months follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.