N/A
N=28
ALS and Airway Clearance (ALSAC) Therapy
Amyotrophic Lateral Sclerosis · Respiratory Muscle Weakness
Bottom Line
View on ClinicalTrials.gov: NCT04947436 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Respiratory Complications Severity — 8.33; 9.0; 7.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- High Frequency Chest Wall Oscillation (Device); Mechanical insufflation/exsufflation (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Respiratory Complications Severity |
8.33; 9.0; 7.8 | — |
| SECONDARY Patient Global Impression of Change (PGIC) |
3.33; 3.00; 4.40 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04947436). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.