CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
High Frequency Chest Wall Oscillation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04947436
NCT04947436N/ACompleted

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

The University of Texas Health Science Center at San Antonio·interventional·Posted Jul 1, 2021·Updated Nov 4, 2021

In Brief

A clinical study evaluating High Frequency Chest Wall Oscillation and Mechanical insufflation/exsufflation for Amyotrophic Lateral Sclerosis and Respiratory Muscle Weakness. Completed, enrolled 28 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsALS Association

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2021
Enrollment StartJan 25, 2012
Primary CompletionSep 21, 2016
Study CompletionSep 17, 2017
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 5.0 years ago

Interventions

High Frequency Chest Wall Oscillationdevice

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.

Mechanical insufflation/exsufflationdevice

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.