ALS and Airway Clearance (ALSAC) Therapy
Completed · Not applicable
Conditions studied: Amyotrophic Lateral Sclerosis, Respiratory Muscle Weakness
In brief
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.
Key facts
- Study ID
- NCT04947436
- Run by
- The University of Texas Health Science Center at San Antonio
- People needed
- 28
- Starts
- 2012-01-25
- Expected to finish
- 2017-09-17
- Last updated by the study team
- 2021-11-04
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- University of Texas Health San Antonio — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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