Respiratory Training in Friedreich's Ataxia

NCT ID: NCT06539598

Last Updated: 2025-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-29

Study Completion Date

2025-08-07

Brief Summary

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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

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Conditions

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Friedreich Ataxia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Respiratory Strength Training (RST)

Intervention Type OTHER

Respiratory Strength training involves inhaling/exhaling against a fix resistant to potentially increase respiratory strength

Interventions

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Respiratory Strength Training (RST)

Respiratory Strength training involves inhaling/exhaling against a fix resistant to potentially increase respiratory strength

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carmen Leon Astudillo, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Clinical Research Center

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB202401099

Identifier Type: -

Identifier Source: org_study_id

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