Respiratory Training in Friedreich's Ataxia

Not Applicable

Not yet recruiting

• Conditions: Friedreich Ataxia
• Interventions: Other: Respiratory Strength Training (RST)

• Registration Number: NCT06539598
• Lead Sponsor: University of Florida

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-30
• Status Verified: 2024-08
• Study Start: 2024-08
• Study First Submitted QC: 2024-08-01
• Last Update Submitted: 2024-08-01
• Study First Posted: 2024-08-06
• Last Update Posted: 2024-08-06
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Respiratory Strength Training (RST)	Respiratory Strength Training (RST)	Participants will receive a respiratory strength training device to take home and use up to 5 times a week for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Maximal Inspiratory Pressure (MIP)	Through study completion (4 months)	Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention
Sniff Nasal Inspiratory Pressure (SNIP)	Through study completion (4 months)	Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention
Maximal Expiratory Pressure (MEP)	Through study completion (4 months)	Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention
Diaphragm Ultrasound	Through study completion (4 months)	Diaphragm movement will be measured through an ultrasound probe positioned on the skin before and after the 12 week intervention.
Force Vital Capacity	Through study completion (4 months)	Forced Vital Capicity will be measured before and after the 12 week intervention
Surface Electromyography (sEMG)	Through study completion (4 months)	sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing
Swallowing	Through study completion (4 months)	Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention.

Trial Locations

Locations (1)

Clinical Research Center; 🇺🇸 Gainesville, Florida, United States