ALS and Airway Clearance (ALSAC) Therapy

Not Applicable

Completed

Conditions: Amyotrophic Lateral Sclerosis
Respiratory Muscle Weakness

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

Registration Number: NCT04947436

Lead Sponsor: The University of Texas Health Science Center at San Antonio

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 28

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Frequency Chest Wall Oscillation	High Frequency Chest Wall Oscillation	-
High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation	Mechanical insufflation/exsufflation	-
Mechanical insufflation/ exsufflation	Mechanical insufflation/exsufflation	-
High Frequency Chest Wall Oscillation and Mechanical insufflation/ exsufflation	High Frequency Chest Wall Oscillation	-

Primary Outcome Measures

Name	Time	Method
Respiratory Complications Severity	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 Outcome Measures

Name	Time	Method
Patient Global Impression of Change (PGIC)	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.