Skip to main content
OpenTrials
Completed

NCT Number: NCT04947436

ALS and Airway Clearance (ALSAC) Therapy

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health San Antonio

San Antonio, Texas, 78229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

Other names: "The Vest"

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.

Other names: Cough Assist

Primary outcomes

  1. Respiratory Complications Severity

    Time frame: Baseline to 6 months

    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.

Secondary outcomes

  1. Patient Global Impression of Change (PGIC)

    Time frame: Baseline to 6 months

    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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Collaborators

  • ALS Association

Registry information

Official study title

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

Acronym: ALSAC

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jul 1, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.