Respiratory Training in Friedreich's Ataxia

University of Florida

Status: Completed

Conditions: Friedreich Ataxia

Treatments: Other: Respiratory Strength Training (RST)

Study type: Interventional

Funder types: Other

Identifiers

NCT06539598

IRB202401099

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Respiratory Strength Training (RST)

Experimental group

Description:

Participants will receive a respiratory strength training device to take home and use up to 5 times a week for 12 weeks.

Treatment:

Other: Respiratory Strength Training (RST)