ALS and Airway Clearance (ALSAC) Therapy (ALSAC)

ALS and Airway Clearance (ALSAC) Is There a Best Therapy for Airway Clearance in Patients With ALS

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.

Study Overview

• Status: Completed
• Conditions: Amyotrophic Lateral Sclerosis; Respiratory Muscle Weakness
• Intervention / Treatment: Device: High Frequency Chest Wall Oscillation; Device: Mechanical insufflation/exsufflation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 21 and above,
2. Probable or definite ALS diagnosis,
3. Peak Cough Flow of <160L/min or complain of issues clearing airway secretions
4. Caregiver must also consent to participate

Exclusion Criteria:

1. Current use of HFCWO or MIE
2. Tracheostomy
3. Congestive heart failure
4. All contraindications for the HFCWO
5. Head and/or neck injury that has not been stabilized;
6. Active hemorrhage with hemodynamic instability;
7. Uncontrolled hypertension;
8. Active or recent gross hemoptysis; and
9. All contraindications for the MIE
10. History of bullous emphysema;
11. Known susceptibility to pneumothorax;
12. Pneumomediastinum; and
13. Recent barotrauma
14. Frontal Temporal Dementia (FTD) - suspected or diagnosed . FTD is a form of dementia found in about 20% of Familial ALS. This dementia interferes with the ability to follow commands and follow through with therapies due to forgetfulness.
15. Patients not able to provide informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: High Frequency Chest Wall Oscillation	Device: High Frequency Chest Wall Oscillation; 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.; Other Names: "The Vest"
Active Comparator: Mechanical insufflation/ exsufflation	Device: Mechanical insufflation/exsufflation; 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.; Other Names: Cough Assist
Active Comparator: High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation	Device: High Frequency Chest Wall Oscillation; 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.; Other Names: "The Vest"; Device: Mechanical insufflation/exsufflation; 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.; Other Names: Cough Assist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio
• Collaborators: ALS Association
• Investigators: Principal Investigator: Donna Gardner, DrPH, University of Texas Health San Antonio

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2012
• Primary Completion (Actual): September 21, 2016
• Study Completion (Actual): September 17, 2017

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: June 30, 2021
• First Posted (Actual): July 1, 2021

Study Record Updates

• Last Update Posted (Actual): November 4, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; Airway Clearance; Mechanical Insufflation Exsufflation; High Frequency Chest Wall Compression Oscillation
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Neuromuscular Manifestations; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Muscle Weakness; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: HSC20120075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Deidentified participant data will be available in result publication and in summary result reporting in ClinicalTrials.gov
• IPD Sharing Time Frame: In a peer review journal post study completion and data analysis
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes