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OpenTrials
Completed

NCT Number: NCT06539598

Respiratory Training in Friedreich's Ataxia

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.

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Key information

Conditions

Friedreich Ataxia Brain Diseases Central Nervous System Diseases Cerebellar Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Metabolic Diseases Mitochondrial Diseases Nervous System Diseases Neurodegenerative Diseases Nutritional and Metabolic Diseases Spinal Cord Diseases Spinocerebellar Degenerations

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Research Center

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Respiratory Strength Training (RST)

Other

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

Primary outcomes

  1. Force Vital Capacity

    Time frame: Through study completion (4 months)

    Forced Vital Capicity will be measured before and after the 12 week intervention

  2. Maximal Inspiratory Pressure (MIP)

    Time frame: Through study completion (4 months)

    Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention

  3. Maximal Expiratory Pressure (MEP)

    Time frame: Through study completion (4 months)

    Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention

  4. Sniff Nasal Inspiratory Pressure (SNIP)

    Time frame: Through study completion (4 months)

    Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention

  5. Swallowing

    Time frame: Through study completion (4 months)

    Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention.

  6. Surface Electromyography (sEMG)

    Time frame: Through study completion (4 months)

    sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing

  7. Diaphragm Ultrasound

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With Friedreich's Ataxia

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 6, 2024
Registry last updated
Nov 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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