N/A
Completed N=28
ALS and Airway Clearance (ALSAC) Therapy
Amyotrophic Lateral Sclerosis · Respiratory Muscle Weakness
Source: ClinicalTrials.gov NCT04947436 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcomePrimary: Respiratory Complications Severity — 8.33; 9.0; 7.8 score on a scale
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.
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 | — |
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. Informational only — not medical advice.