Amyotrophic Lateral Sclerosis Clinical Trial
— ALSACOfficial title:
ALS and Airway Clearance (ALSAC) Is There a Best Therapy for Airway Clearance in Patients With ALS
Verified date | October 2021 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | September 17, 2017 |
Est. primary completion date | September 21, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: 1. Age 21 and above, 2. Probable or definite ALS diagnosis, 3. Peak Cough Flow of <160L/min or complain of issues clearing airway secretions 4. Caregiver must also consent to participate Exclusion Criteria: 1. Current use of HFCWO or MIE 2. Tracheostomy 3. Congestive heart failure 4. All contraindications for the HFCWO 5. Head and/or neck injury that has not been stabilized; 6. Active hemorrhage with hemodynamic instability; 7. Uncontrolled hypertension; 8. Active or recent gross hemoptysis; and 9. All contraindications for the MIE 10. History of bullous emphysema; 11. Known susceptibility to pneumothorax; 12. Pneumomediastinum; and 13. Recent barotrauma 14. 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. 15. Patients not able to provide informed consent. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio | ALS Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Respiratory Complications Severity | 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. | Baseline to 6 months | |
Secondary | Patient Global Impression of Change (PGIC) | 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. | Baseline to 6 months |
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