CompletedNot Applicable

Respiratory Training in Friedreich's Ataxia

United States1 participantsStarted 2024-08-29

Plain-language summary

This is a prospective interventional study of patients with Friedreich's Ataxia that receive respiratory strength training for a period of 12 weeks with two research visits at the beginning and at the end of the study period. Visits include swallowing evaluation with fiberoptic endoscopic evaluation of swallowing, pulmonary function testing, surface electromyography and patient surveys.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Force Vital Capacity

Timeframe: Through study completion (4 months)

Maximal Inspiratory Pressure (MIP)

Timeframe: Through study completion (4 months)

Maximal Expiratory Pressure (MEP)

Timeframe: Through study completion (4 months)

Sniff Nasal Inspiratory Pressure (SNIP)

Timeframe: Through study completion (4 months)

Swallowing

Timeframe: Through study completion (4 months)

Surface Electromyography (sEMG)

Timeframe: Through study completion (4 months)

Diaphragm Ultrasound

Timeframe: Through study completion (4 months)

Trial details

NCT IDNCT06539598

SponsorUniversity of Florida

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-07

View on ClinicalTrials.gov More Friedreich Ataxia trials

Plain-language summary

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Force Vital Capacity

Timeframe: Through study completion (4 months)

Maximal Inspiratory Pressure (MIP)

Timeframe: Through study completion (4 months)

Maximal Expiratory Pressure (MEP)

Timeframe: Through study completion (4 months)

Sniff Nasal Inspiratory Pressure (SNIP)

Timeframe: Through study completion (4 months)

Swallowing

Timeframe: Through study completion (4 months)

Surface Electromyography (sEMG)

Timeframe: Through study completion (4 months)

Diaphragm Ultrasound

Timeframe: Through study completion (4 months)