Respiratory training for patients with Friedreich's Ataxia
Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With Friedreich's Ataxia
This study is testing if a 12-week breathing exercise program can help improve lung function and quality of life for people with Friedreich's Ataxia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT06539598 on ClinicalTrials.gov |
What this trial studies
This interventional study focuses on patients diagnosed with Friedreich's Ataxia who will undergo a 12-week program of respiratory strength training. Participants will have two research visits, one at the beginning and one at the end of the training period, during which they will undergo various evaluations including swallowing assessments, pulmonary function tests, and surface electromyography. The aim is to assess the impact of respiratory training on their overall respiratory function and quality of life.
Who should consider this trial
Good fit: Ideal candidates are individuals with confirmed genetic testing for Friedreich's Ataxia who can perform pulmonary function testing.
Not a fit: Patients with recent antibiotic use, systemic corticosteroid prescriptions, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve respiratory function and quality of life for patients with Friedreich's Ataxia.
How similar studies have performed: While there may be limited studies specifically on respiratory training in Friedreich's Ataxia, similar approaches in other neuromuscular conditions have shown promise.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * confirmed genetic testing of Friedreich's Ataxia * have an overall DIGEST score of 1 or higher based on FEES screening * are able to perform pulmonary function testing Exclusion Criteria: * have been on antibiotics within 15 days prior to baseline screening. * have been prescribed systemic corticosteroids or neuromuscular blocking agents within 15 days of the baseline screening * have an allergy or contraindication to topical lidocaine or oxymetazoline * have any other concurrent medical condition which, in the opinion of the investigators, would make the subject inappropriate to participate in testing or respiratory exercise
Where this trial is running
Gainesville, Florida
- Clinical Research Center — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Carmen Leon Astudillo, MD — University of Florida
- Study coordinator: Mackenzi Coker, MS, CCC-SLP
- Email: mcoker@peds.ufl.edu
- Phone: 3522948754
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.