ALS and Airway Clearance (ALSAC) Therapy

NCT04947436 | Completed Results FDA Device

• 1 other identifier: HSC20120075
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis; Respiratory Muscle Weakness

Keywords

Amyotrophic Lateral Sclerosis; Airway Clearance; Mechanical Insufflation Exsufflation; High Frequency Chest Wall Compression Oscillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Global Impression of Change (PGIC)

  Baseline to 6 months

Study Arms (3)

High Frequency Chest Wall Oscillation

ACTIVE COMPARATOR

Device: High Frequency Chest Wall Oscillation

Mechanical insufflation/ exsufflation

ACTIVE COMPARATOR

Device: Mechanical insufflation/exsufflation

High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation

ACTIVE COMPARATOR

Device: High Frequency Chest Wall Oscillation; Device: Mechanical insufflation/exsufflation

Interventions

High Frequency Chest Wall Oscillation DEVICE

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"

High Frequency Chest Wall Oscillation; High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation

Mechanical insufflation/exsufflation DEVICE

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

High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation; Mechanical insufflation/ exsufflation

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Current use of HFCWO or MIE
• Tracheostomy
• Congestive heart failure
• All contraindications for the HFCWO
• Head and/or neck injury that has not been stabilized;
• Active hemorrhage with hemodynamic instability;
• Uncontrolled hypertension;
• Active or recent gross hemoptysis; and
• All contraindications for the MIE
• History of bullous emphysema;
• Known susceptibility to pneumothorax;
• Pneumomediastinum; and
• Recent barotrauma
• 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.
• Patients not able to provide informed consent.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead
• ALS Association: collaborator

Study Sites (1)

University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Respiratory Therapy; Therapeutics

Limitations and Caveats

Limitations include small sample size due to length of time associated with the intervention and the progression of the disease.

Results Point of Contact

• Title: Dr. Donna Gardner
• Organization: University of Texas Health San Antonio

dgardner62001@gmail.com

210-450-8479

Study Officials

• Donna Gardner, DrPH

  University of Texas Health San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be blinded to the intervention
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A single-blind parallel group design in which 60 patients with probable or definite ALS will be randomized equally into three groups (20 per group) over a period of 12 months

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 1, 2021
• Study Start: January 25, 2012
• Primary Completion: September 21, 2016
• Study Completion: September 17, 2017
• Last Updated: November 4, 2021
• Results First Posted: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: In a peer review journal post study completion and data analysis

Locations

US (1)