Amyotrophic Lateral SclerosisMI-PALSNCT06119087
Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
A study testing Mechanical insufflation in people with Amyotrophic Lateral Sclerosis and Chronic Respiratory Failure, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis, Chronic Respiratory Failure, Airway Clearance Impairment
- What is being tested?
- Mechanical insufflation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to 30 Jul 2026
- 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
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years.
- Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
- Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
- Willingness and ability to participate in study procedures.
Who cannot join
- Age <18 years old.
- Inability to perform a cough peak flow or spirometry manuever
- Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
- Current use of MI-E (also known as a "cough assist device") for airway clearance. Please note that patients can start use of a MI-E device subsequent to enrollment while currently being followed for the study.
- Active enrollment in hospice.
- Current tracheostomy.
Show all 20Show fewer
- Presence of cognitive dysfunction that would impair ability to complete study procedures, as determined by neurology attending physician.
- Absence of an able and willing caregiver to assist with MI twice daily as specified in the protocol.
- Pregnancy
- Medical history of any of the following:
- Recent hemoptysis
- Recent barotrauma
- History of emphysema of any kind (including bullous emphysema)
- History of or known susceptibility to pneumothorax
- History of or known susceptibility to pneumomediastinum
- Chronic obstructive pulmonary disease
- Uncontrolled asthma (defined as recent exacerbation requiring corticosteroids in the previous 30 days)
- Symptomatic cardiomyopathy (heart failure) with left ventricular ejection fraction less than 50%
- History of right heart failure or pulmonary hypertension
- Current smoker or tobacco use within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn.
Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF).
Read more
Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily.
Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.
- Conditions
- Amyotrophic Lateral Sclerosis, Chronic Respiratory Failure, Airway Clearance Impairment, Neuromuscular Diseases
- Being tested
- Mechanical insufflation
- Keywords
- amyotrophic lateral sclerosis, chronic respiratory failure, neuromuscular weakness, mechanical insufflation-exsufflation, peak cough flow
- Medical subject headings
- Amyotrophic Lateral Sclerosis, Neuromuscular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mechanical insufflationDevice
Mechanical insufflation (MI) is a chest physiotherapy exercise that will be performed using a type of mechanical insufflator-exsufflator (MI-E) known as the BiWaze Cough device. The device connects to a tube that can interface with a patient using either a facemask or mouthpiece.
Mechanical insufflation is a chest physiotherapy exercise that passively inflates the chest with positive pressure that is delivered in coordination with the patient's own inspiratory timing until maximal inflation capacity (MIC), determined by the patient or maximal chest rise on visual inspection. At MIC, the patient passively exhales, which completes one "cycle". Prior literature has used a "dose" of 5 sets of 5 cycles once or twice daily. The maneuver is usually performed with assistance of a caregiver to hold the mask or mouthpiece in place.
| Study group | Role | What they receive |
|---|---|---|
| Mechanical insufflation | Experimental | Participants will be asked to perform mechanical insufflation using the BiWaze cough device as 5 sets of 5 insufflations twice daily for 6 months. Receives: Device: Mechanical insufflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
peak cough flow (PCF)
PCF in liters/minute as measured by use of a peak flow meter while the patient is in a seated upright position. An alternative device for measuring PCF can be the use of a handheld spirometer and using the measured peak expiratory flow by multiplying by 60 to convert from liters/second to liters/minute.
The subject must be seated in an upright position and the interface must include a mouthpiece or an oronasal mask. Subjects are asked to perform a deep inhalation followed by a maximal cough.
Measured: 6 months
Secondary outcomes (9)
Forced vital capacity (FVC)
Defined as maximal volume, in liters, that a person can exhale forcefully after a complete inhalation.
Measured using a spirometer connected to a face mask or mouthpiece in the sitting and upright position.
Measured: 6 months
Maximal inspiratory pressure (MIP)
Defined as the maximum pressure, in cmH2O, generated when the subject exhales as much air as possible and then immediately inhales as forcefully as possible.
Measured: 6 months
Maximal expiratory pressure (MEP)
Defined as the maximum pressure, in cmH2O, generated when the subject inhales as much air as possible and then immediately exhales as forcefully as possible.
Measured using a hand-held manual or digital manometer connected to a mouthpiece or mask in the sitting and upright position.
Measured: 6 months
Maximum insufflation capacity (MIC)
Defined as exhaled volume, in liters, immediately following a MI maneuver to maximum insufflation capacity.
Measured using a spirometer connected to a face mask or mouthpiece, in the sitting and upright position.
Measured: 6 months
Maximum insufflation capacity assisted peak cough flow
Defined as the peak cough flow generated from MIC.
Lungs are inflated to MIC using MI and before the subject exhales they insert a peak flow meter in their mouth and follow with a peak cough flow as described above.
Measured: 6 months
MIC-FVC difference
defined by subtracting the FVC from the MIC
Measured: 6 months
Transcutaneous carbon dioxide
Defined as the average value in mmHg from a daytime in-clinic measurement over a 15-minute transcutaneous recording.
Measured using a Sentec transcutaneous digital monitoring system while the subject is sitting upright in a chair or wheelchair. The transcutaneous sensor can be placed on the subject forehead, cheek, or earlobe.
Measured: 6 months
ALS Functional Rating Scale - Revised (ALSFRS-R) dyspnea and orthopnea scores
The ALSFRS-R is a 12-item standardized questionnaire to assess the motor function status of an individual with ALS. The ALSFRS-R is assessed by a research staff member who has been certified for performance of the ALSFRS-R.
The dyspnea score is one of the questions focusing on level of shortness of breath, scored on a scale of 0 to 4, with 4 being no symptoms at all and 0 being severely symptomatic with consideration of mechanical respiratory support.
The orthopnea score is one of the questions focused on breathing symptoms and difficulty sleeping while lying supine, scored on a scale of 0 to 4, with 4 being no symptoms at all and 0 being severely symptomatic with inability to sleep.
Measured: 6 months
Global rate of change score for peak cough flow
The global rate of change score for the peak cough flow will ask patients how effective they think their cough is today by rating it on a Likert scale from -7 (extremely impaired) to +7 (extremely strong).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start12 Sep 2024
- Primary completion30 Jul 2026
- Study completion30 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Amyotrophic Lateral SclerosisStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- single-center, single-arm feasibility pilot study of in 20 patients with ALS.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jason Ackrivo, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119087
- Sponsor's protocol ID
- 854981
- Acronym
- MI-PALS
- Status last verified
- Aug 2026
- First submitted
- 31 Oct 2023
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaminska M, Browman F, Trojan DA, Genge A, Benedetti A, Petrof BJ. Feasibility of Lung Volume Recruitment in Early Neuromuscular Weakness: A Comparison Between Amyotrophic Lateral Sclerosis, Myotonic Dystrophy, and Postpolio Syndrome. PM R. 2015 Jul;7(7):677-684. doi: 10.1016/j.pmrj.2015.04.001. Epub 2015 Apr 3.
PubMed 25845857Katz SL, Barrowman N, Monsour A, Su S, Hoey L, McKim D. Long-Term Effects of Lung Volume Recruitment on Maximal Inspiratory Capacity and Vital Capacity in Duchenne Muscular Dystrophy. Ann Am Thorac Soc. 2016 Feb;13(2):217-22. doi: 10.1513/AnnalsATS.201507-475BC.
PubMed 26599476McKim DA, Katz SL, Barrowman N, Ni A, LeBlanc C. Lung volume recruitment slows pulmonary function decline in Duchenne muscular dystrophy. Arch Phys Med Rehabil. 2012 Jul;93(7):1117-22. doi: 10.1016/j.apmr.2012.02.024. Epub 2012 Mar 12.
PubMed 22421625Chiou M, Bach JR, Jethani L, Gallagher MF. Active lung volume recruitment to preserve vital capacity in Duchenne muscular dystrophy. J Rehabil Med. 2017 Jan 19;49(1):49-53. doi: 10.2340/16501977-2144.
PubMed 27630091Mustfa N, Aiello M, Lyall RA, Nikoletou D, Olivieri D, Leigh PN, Davidson AC, Polkey MI, Moxham J. Cough augmentation in amyotrophic lateral sclerosis. Neurology. 2003 Nov 11;61(9):1285-7. doi: 10.1212/01.wnl.0000092018.56823.02.
PubMed 14610141Chatwin M, Bush A, Simonds AK. Outcome of goal-directed non-invasive ventilation and mechanical insufflation/exsufflation in spinal muscular atrophy type I. Arch Dis Child. 2011 May;96(5):426-32. doi: 10.1136/adc.2009.177832. Epub 2010 Jun 23.
PubMed 20573738Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91. doi: 10.1097/01.phm.0000151941.97266.96.
PubMed 15668554Miske LJ, Hickey EM, Kolb SM, Weiner DJ, Panitch HB. Use of the mechanical in-exsufflator in pediatric patients with neuromuscular disease and impaired cough. Chest. 2004 Apr;125(4):1406-12. doi: 10.1378/chest.125.4.1406.
PubMed 15078753Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6. doi: 10.1378/chest.118.5.1390.
PubMed 11083691Bach JR, Goncalves MR, Hamdani I, Winck JC. Extubation of patients with neuromuscular weakness: a new management paradigm. Chest. 2010 May;137(5):1033-9. doi: 10.1378/chest.09-2144. Epub 2009 Dec 29.
PubMed 20040608Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gile S, Winck JC, Goncalves MR. At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis. Am J Phys Med Rehabil. 2010 May;89(5):401-6. doi: 10.1097/PHM.0b013e3181d89760.
PubMed 20407305Chatwin M, Toussaint M, Goncalves MR, Sheers N, Mellies U, Gonzales-Bermejo J, Sancho J, Fauroux B, Andersen T, Hov B, Nygren-Bonnier M, Lacombe M, Pernet K, Kampelmacher M, Devaux C, Kinnett K, Sheehan D, Rao F, Villanova M, Berlowitz D, Morrow BM. Airway clearance techniques in neuromuscular disorders: A state of the art review. Respir Med. 2018 Mar;136:98-110. doi: 10.1016/j.rmed.2018.01.012. Epub 2018 Feb 6.
PubMed 29501255Miller RG, Jackson CE, Kasarskis EJ, England JD, Forshew D, Johnston W, Kalra S, Katz JS, Mitsumoto H, Rosenfeld J, Shoesmith C, Strong MJ, Woolley SC; Quality Standards Subcommittee of the American Academy of Neurology. Practice parameter update: the care of the patient with amyotrophic lateral sclerosis: drug, nutritional, and respiratory therapies (an evidence-based review): report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 2009 Oct 13;73(15):1218-26. doi: 10.1212/WNL.0b013e3181bc0141.
PubMed 19822872Sawnani H, Mayer OH, Modi AC, Pascoe JE, McConnell K, McDonough JM, Rutkowski AM, Hossain MM, Szczesniak R, Tadesse DG, Schuler CL, Amin R. Randomized trial of lung hyperinflation therapy in children with congenital muscular dystrophy. Pediatr Pulmonol. 2020 Sep;55(9):2471-2478. doi: 10.1002/ppul.24954. Epub 2020 Jul 20.
PubMed 32658385McDonald LA, Berlowitz DJ, Howard ME, Rautela L, Chao C, Sheers N. Pneumothorax in neuromuscular disease associated with lung volume recruitment and mechanical insufflation-exsufflation. Respirol Case Rep. 2019 Jun 13;7(6):e00447. doi: 10.1002/rcr2.447. eCollection 2019 Aug.
PubMed 31210952
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Insufflation in the Philadelphia Amyotrophic Lateral Sclerosis Cohort (MI-PALS) Study
- ClinicalTrials.gov ID
- NCT06119087
- Acronym / sponsor ID
- MI-PALS / 854981
- Conditions
- Amyotrophic Lateral Sclerosis, Chronic Respiratory Failure, Airway Clearance Impairment, Neuromuscular Diseases
- Keywords
- amyotrophic lateral sclerosis, chronic respiratory failure, neuromuscular weakness, mechanical insufflation-exsufflation, peak cough flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 30 Jul 2026 (actual)
- Study completion
- 30 Jul 2026 (actual)
- First posted
- 7 Nov 2023 (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.
The goal of this clinical trial is to learn how doing mechanical insufflation (MI) using a mechanical insufflator-exsufflator (MI-E) device affects breathing in early amyotrophic lateral sclerosis (ALS). This will be a single-center, single-arm study of MI in 20 patients with ALS at Penn.
Based on prior research, we believe that 6-months of MI may slow decline in cough strength, measured as peak cough flow (PCF).
Participants will perform MI using a device designed for mechanical insufflation-exsufflation (MI-E) known as the BiWaze Cough system. The BiWaze Cough is used for mucus clearance . It is connected to tubing and mouthpiece (or mask). The device will use programmed pressure and timing settings. An insufflation includes inflating the lungs for a maximal size inhalation before exhaling. The daily routine for the device includes 5 sets of 5 insufflations twice daily.
Researchers will compare how use of MI in early ALS affects peak cough flow compared to 20 subjects who did not use MI in early ALS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, single-arm feasibility pilot study of in 20 patients with ALS.
| Arm | Type | Receives |
|---|---|---|
| Mechanical insufflation | Experimental | Device: Mechanical insufflationParticipants will be asked to perform mechanical insufflation using the BiWaze cough device as 5 sets of 5 insufflations twice daily for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provision of signed and dated informed consent form.
- Stated willingness to comply with all study procedures and availability for the duration of the study.
- Age ≥18 years.
- Diagnosed with amyotrophic lateral sclerosis using the Gold Coast Criteria.
- Have an able and willing caregiver to assist with mechanical insufflation on a daily basis.
Key exclusion criteria (20 listed)
- Age <18 years old.
- Inability to perform a cough peak flow or spirometry manuever
- Current use of non-invasive ventilation (NIV), bi-level positive pressure ventilation, or "Bi-PAP" or physician prescribing NIV on day of potential enrollment.
- Current use of MI-E (also known as a "cough assist device") for airway clearance. Please note that patients can start use of a MI-E device subsequent to enrollment while currently being followed for the study.
- Active enrollment in hospice.
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 |
|---|---|---|
| Mechanical insufflationMechanical insufflation (MI) is a chest physiotherapy exercise that will be performed using a type of mechanical insufflator-exsufflator (MI-E) known as the BiWaze Cough device. The device connects to a tube that can interface with a patient using either a facemask or mouthpiece. Mechanical insufflation is a chest physiotherapy exercise that passively inflates the chest with positive pressure that is delivered in coordination with the patient's own inspiratory timing until maximal inflation capacity (MIC), determined by the patient or maximal chest rise on visual inspection. At MIC, the patient passively exhales, which completes one "cycle". Prior literature has used a "dose" of 5 sets of 5 cycles once or twice daily. The maneuver is usually performed with assistance of a caregiver to hold the mask or mouthpiece in place. | Device | Mechanical insufflation |
Primary outcome
peak cough flow (PCF)
Time frame: 6 months
PCF in liters/minute as measured by use of a peak flow meter while the patient is in a seated upright position. An alternative device for measuring PCF can be the use of a handheld spirometer and using the measured peak expiratory flow by multiplying by 60 to convert from liters/second to liters/minute. The subject must be seated in an upright position and the interface must include a mouthpiece or an oronasal mask. Subjects are asked to perform a deep inhalation followed by a maximal cough.
9 secondary outcomes
Forced vital capacity (FVC)
Time frame: 6 months
Maximal inspiratory pressure (MIP)
Time frame: 6 months
Maximal expiratory pressure (MEP)
Time frame: 6 months
Maximum insufflation capacity (MIC)
Time frame: 6 months
Maximum insufflation capacity assisted peak cough flow
Time frame: 6 months
MIC-FVC difference
Time frame: 6 months
Transcutaneous carbon dioxide
Time frame: 6 months
ALS Functional Rating Scale - Revised (ALSFRS-R) dyspnea and orthopnea scores
Time frame: 6 months
Global rate of change score for peak cough flow
Time frame: 6 months
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 12 Aug 2026.
- Background: PubMed 25845857Kaminska M, Browman F, Trojan DA, Genge A, Benedetti A, Petrof BJ. Feasibility of Lung Volume Recruitment in Early Neuromuscular Weakness: A Comparison Between Amyotrophic Lateral Sclerosis, Myotonic Dystrophy, and Postpolio Syndrome. PM R. 2015 Jul;7(7):677-684. doi: 10.1016/j.pmrj.2015.04.001. Epub 2015 Apr 3.
- Background: PubMed 26599476Katz SL, Barrowman N, Monsour A, Su S, Hoey L, McKim D. Long-Term Effects of Lung Volume Recruitment on Maximal Inspiratory Capacity and Vital Capacity in Duchenne Muscular Dystrophy. Ann Am Thorac Soc. 2016 Feb;13(2):217-22. doi: 10.1513/AnnalsATS.201507-475BC.
- Background: PubMed 22421625McKim DA, Katz SL, Barrowman N, Ni A, LeBlanc C. Lung volume recruitment slows pulmonary function decline in Duchenne muscular dystrophy. Arch Phys Med Rehabil. 2012 Jul;93(7):1117-22. doi: 10.1016/j.apmr.2012.02.024. Epub 2012 Mar 12.
- Background: PubMed 27630091Chiou M, Bach JR, Jethani L, Gallagher MF. Active lung volume recruitment to preserve vital capacity in Duchenne muscular dystrophy. J Rehabil Med. 2017 Jan 19;49(1):49-53. doi: 10.2340/16501977-2144.
- Background: PubMed 14610141Mustfa N, Aiello M, Lyall RA, Nikoletou D, Olivieri D, Leigh PN, Davidson AC, Polkey MI, Moxham J. Cough augmentation in amyotrophic lateral sclerosis. Neurology. 2003 Nov 11;61(9):1285-7. doi: 10.1212/01.wnl.0000092018.56823.02.
- Background: PubMed 20573738Chatwin M, Bush A, Simonds AK. Outcome of goal-directed non-invasive ventilation and mechanical insufflation/exsufflation in spinal muscular atrophy type I. Arch Dis Child. 2011 May;96(5):426-32. doi: 10.1136/adc.2009.177832. Epub 2010 Jun 23.
- Background: PubMed 15668554Vianello A, Corrado A, Arcaro G, Gallan F, Ori C, Minuzzo M, Bevilacqua M. Mechanical insufflation-exsufflation improves outcomes for neuromuscular disease patients with respiratory tract infections. Am J Phys Med Rehabil. 2005 Feb;84(2):83-8; discussion 89-91. doi: 10.1097/01.phm.0000151941.97266.96.
- Background: PubMed 15078753Miske LJ, Hickey EM, Kolb SM, Weiner DJ, Panitch HB. Use of the mechanical in-exsufflator in pediatric patients with neuromuscular disease and impaired cough. Chest. 2004 Apr;125(4):1406-12. doi: 10.1378/chest.125.4.1406.
- Background: PubMed 11083691Tzeng AC, Bach JR. Prevention of pulmonary morbidity for patients with neuromuscular disease. Chest. 2000 Nov;118(5):1390-6. doi: 10.1378/chest.118.5.1390.
- Background: PubMed 20040608Bach JR, Goncalves MR, Hamdani I, Winck JC. Extubation of patients with neuromuscular weakness: a new management paradigm. Chest. 2010 May;137(5):1033-9. doi: 10.1378/chest.09-2144. Epub 2009 Dec 29.
- Background: PubMed 20407305Vitacca M, Paneroni M, Trainini D, Bianchi L, Assoni G, Saleri M, Gile S, Winck JC, Goncalves MR. At home and on demand mechanical cough assistance program for patients with amyotrophic lateral sclerosis. Am J Phys Med Rehabil. 2010 May;89(5):401-6. doi: 10.1097/PHM.0b013e3181d89760.
- Background: PubMed 29501255Chatwin M, Toussaint M, Goncalves MR, Sheers N, Mellies U, Gonzales-Bermejo J, Sancho J, Fauroux B, Andersen T, Hov B, Nygren-Bonnier M, Lacombe M, Pernet K, Kampelmacher M, Devaux C, Kinnett K, Sheehan D, Rao F, Villanova M, Berlowitz D, Morrow BM. Airway clearance techniques in neuromuscular disorders: A state of the art review. Respir Med. 2018 Mar;136:98-110. doi: 10.1016/j.rmed.2018.01.012. Epub 2018 Feb 6.
- 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.
Jason Ackrivo, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mechanical insufflation in people with Amyotrophic Lateral Sclerosis and Chronic Respiratory Failure, run by University of Pennsylvania at 1 site in United States.
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 6 inclusion and 20 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 12 Aug 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 United States. 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?
peak cough flow (PCF) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06119087, which also lists 32 linked publications.
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 12 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.