Friedreich AtaxiaNCT06539598
Respiratory Training in Friedreich's Ataxia
A study testing Respiratory Strength Training (RST) in people with Friedreich Ataxia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Friedreich Ataxia
- What is being tested?
- Respiratory Strength Training (RST)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2024to 7 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Clinical Research Center
Gainesville, Florida, 32610
About this study
Official title: Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With 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.
- Conditions
- Friedreich Ataxia
- Being tested
- Respiratory Strength Training (RST)
- Medical subject headings
- Friedreich Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Respiratory Strength Training (RST)Other
Respiratory Strength training involves inhaling/exhaling against a fix resistant to potentially increase respiratory strength
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Strength Training (RST) | Experimental | Participants will receive a respiratory strength training device to take home and use up to 5 times a week for 12 weeks. Receives: Other: Respiratory Strength Training (RST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Force Vital Capacity
Forced Vital Capicity will be measured before and after the 12 week intervention
Measured: Through study completion (4 months)
Maximal Inspiratory Pressure (MIP)
Maximal Inspiratory Pressure (MIP) will be measured before and after the 12 week intervention
Measured: Through study completion (4 months)
Maximal Expiratory Pressure (MEP)
Maximal Expiratory Pressure (MEP) will be measured before and after the 12 week intervention
Measured: Through study completion (4 months)
Sniff Nasal Inspiratory Pressure (SNIP)
Sniff Nasal Inspiratory Pressure (SNIP) will be measured before and after the 12 week intervention
Measured: Through study completion (4 months)
Swallowing
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention.
Measured: Through study completion (4 months)
Surface Electromyography (sEMG)
sEMG will be placed on the skin to measure muscle activity involved in breathing and swallowing
Measured: Through study completion (4 months)
Diaphragm Ultrasound
Diaphragm movement will be measured through an ultrasound probe positioned on the skin before and after the 12 week intervention.
Measured: Through study completion (4 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2024
- Study start29 Aug 2024
- Primary completion7 Aug 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Friedreich AtaxiaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Leon Astudillo, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06539598
- Sponsor's protocol ID
- IRB202401099
- Status last verified
- Sep 2024
- First submitted
- 30 Jul 2024
- Last updated
- 3 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Respiratory Training in Swallowing and Respiratory Function in Patients With Friedreich's Ataxia
- ClinicalTrials.gov ID
- NCT06539598
- Acronym / sponsor ID
- IRB202401099
- Conditions
- Friedreich Ataxia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 29 Aug 2024 (actual)
- Primary completion
- 7 Aug 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 6 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory Strength Training (RST) | Experimental | Other: 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Respiratory Strength Training (RST)Respiratory Strength training involves inhaling/exhaling against a fix resistant to potentially increase respiratory strength | Other | Respiratory Strength Training (RST) |
Primary outcome
Force Vital Capacity
Time frame: Through study completion (4 months)
Forced Vital Capicity will be measured before and after the 12 week intervention
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
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
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
Swallowing
Time frame: Through study completion (4 months)
Fiberoptic Endoscopic Evaluation of Swallowing (FEES) will be measured before and after the 12 week intervention.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carmen Leon Astudillo, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Respiratory Strength Training (RST) in people with Friedreich Ataxia, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Force Vital Capacity (time frame: Through study completion (4 months)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2025.