An interventional study of High Frequency Chest Wall Oscillation and Mechanical insufflation/exsufflation in Amyotrophic Lateral Sclerosis and Respiratory Muscle Weakness, sponsored by The University of Texas Health Science Center at San Antonio. Completed at 1 site in United States. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2021-11-04.
Sponsored by The University of Texas Health Science Center at San Antonio · Not applicable, Interventional, and Treatment
Patients will receive one of three respiratory therapy interventions for airway clearance assistance: 1) High frequency chest wall oscillation (HFCWO) and mechanical insufflation/exsufflation (MIE), 2) HFCWO or 3) MIE. The study period will be six months and include three clinic visits, baseline and follow-up visits at 3 and 6 months, and 6 monthly home visits by the respiratory therapist.
The proposed project includes both the HFCWO and MIE and will capitalize on the specific goals of each therapy and address the problem as a whole rather than piece-meal. The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many patients diagnosed with ALS are unable to expel the secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows to pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx. The MIE, a noninvasive therapy, removes secretions in patients who have an ineffective cough because the peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions. Logically, the two mechanisms of action of these devices should work synergistically to produce effective airway clearance to keep the lungs clear, healthy and reduce the risk of infections from stagnant secretions. Respiratory infections are especially serious for patients with ALS because the patient is not able to recuperate from infections as quickly as a person without ALS. The objective is to determine if changing the use of existing respiratory therapy devices can improve the physical and psychosocial health and quality of life for patients diagnosed with ALS and caregivers.
601 studies on the registry are indexed under Muscle Weakness; 99 are open to participants now.
This study's enrollment of 28 is below the median of 46 across 444 interventional studies indexed under Muscle Weakness.
Browse Muscle Weakness studies →The University of Texas Health Science Center at San Antonio is the lead sponsor of 435 studies on the registry; 88 are open to participants now.
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Exclusion Criteria:
Device: High Frequency Chest Wall Oscillation
Device: Mechanical insufflation/exsufflation
Device: High Frequency Chest Wall Oscillation · Device: Mechanical insufflation/exsufflation
The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
Also known as: "The Vest"
A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
Also known as: Cough Assist
Respiratory Complications Severity
A 9-item instrument will be used to record change from baseline to 6 months in respiratory complications. These are scored on a scale from best (no complications) to worst (death due to respiratory complications) throughout the study period. Scores range from 0-9 with a score of a 9 indicating no complications.
Time frame: Baseline to 6 months
Patient Global Impression of Change (PGIC)
This outcome is assessed and recorded as a number from 1-5 with 1 indicating the worst outcome (markedly worse) and 5 indicating best outcome (markedly better) since starting the study.
Time frame: Baseline to 6 months
Patients and their caregivers (PAC) were randomized into one of three groups. The PAC completed perception of problem and quality of life surveys.
| Milestone | High Frequency Chest Wall Oscillation | Mechanical Insufflation/ Exsufflation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation |
|---|---|---|---|
| Started | 7 | 10 | 11 |
| Completed | 3 | 2 | 5 |
| Not completed | 4 | 8 | 6 |
| Withdrew: Lost to follow-up | 3 | 7 | 5 |
| Withdrew: Death | 1 | 1 | 1 |
A 9-item instrument will be used to record change from baseline to 6 months in respiratory complications. These are scored on a scale from best (no complications) to worst (death due to respiratory complications) throughout the study period. Scores range from 0-9 with a score of a 9 indicating no complications.
| score on a scale | High Frequency Chest Wall Oscillation | Mechanical Insufflation/ Exsufflation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation |
|---|---|---|---|
| Respiratory Complications Severity | 8.33 ± 1.15 | 9.0 ± 0 | 7.8 ± 1.64 |
This outcome is assessed and recorded as a number from 1-5 with 1 indicating the worst outcome (markedly worse) and 5 indicating best outcome (markedly better) since starting the study.
| score on a scale | High Frequency Chest Wall Oscillation | Mechanical Insufflation/ Exsufflation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation |
|---|---|---|---|
| Patient Global Impression of Change (PGIC) | 3.33 ± 0.58 | 3.00 ± 0 | 4.40 ± 0.96 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| High Frequency Chest Wall Oscillation | 1/7 (14.3%) | 0/7 (0%) | 0/7 (0%) |
| Mechanical Insufflation/ Exsufflation | 1/10 (10%) | 0/10 (0%) | 0/10 (0%) |
| High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation | 1/11 (9.1%) | 0/11 (0%) | 0/11 (0%) |
| Age, Categorical(Participants) | High Frequency Chest Wall Oscillation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation | Mechanical Insufflation/ Exsufflation | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 7 | 3 | 14 |
| >=65 years | 3 | 4 | 7 | 14 |
| Sex: Female, Male(Participants) | High Frequency Chest Wall Oscillation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation | Mechanical Insufflation/ Exsufflation | Total |
|---|---|---|---|---|
| Female | 4 | 4 | 5 | 13 |
| Male | 3 | 7 | 5 | 15 |
| Race/Ethnicity, Customized(Participants) | High Frequency Chest Wall Oscillation | High Frequency Chest Wall Oscillation and Mechanical Insufflation/ Exsufflation | Mechanical Insufflation/ Exsufflation | Total |
|---|---|---|---|---|
| Hispanic-Non White | 2 | 3 | 2 | 7 |
| White | 5 | 6 | 7 | 18 |
| Black | 0 | 2 | 1 | 3 |
Plan to share: Yes — Deidentified participant data will be available in result publication and in summary result reporting in ClinicalTrials.gov
Supporting information: Sap
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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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The University of Texas Health Science Center at San Antonio