Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
NCT ID: NCT03645031
Last Updated: 2025-05-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
29 participants
INTERVENTIONAL
2018-10-01
2023-06-02
Brief Summary
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Detailed Description
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The investigators propose to study mechanisms of respiratory plasticity associated with a single presentation of mild AIH. The fundamental hypothesis guiding this proposal is that even a single AIH trial improves respiratory (and non-respiratory) motor function in ALS patients procedure. Participants will then be asked to breathe air with reduced oxygen for short periods of time, for a duration of 45 minutes. The activity of your muscles and your heart function will be monitored throughout the procedure.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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ALS Group
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia
AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia
Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
Healthy Control Group
Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH), as well as, the 45 minute sham AIH session, consisting of breathing air with normal oxygen levels. Breathing, muscle activity and heart activity will be monitored before, during and after both procedures.
Acute Intermittent Hypoxia
AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia
Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
Interventions
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Acute Intermittent Hypoxia
AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
Sham Acute Intermittent Hypoxia
Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* clinical diagnosis of ALS
* baseline FVC \>60% predicted for age, sex and height.
Exclusion Criteria
* diagnosed cardiovascular disease
* a BMI \>35 kg/m2
* currently take selective serotonin reuptake inhibitors (SSRI)
* history of seizures
* history of hospitalization for sepsis
* respiratory infection or took antibiotic medications within the past 4 weeks
* use external respiratory support during any waking hours
* participate in a pharmaceutical trial to treat ALS
* have any other medical condition the PI or medical director identify would make it unsuitable to participate.
21 Years
75 Years
ALL
Yes
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Barbara K Smith, PT, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Clinical Research Center
Gainesville, Florida, United States
University of Florida
Gainesville, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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OCR18018
Identifier Type: OTHER
Identifier Source: secondary_id
IRB201801131
Identifier Type: -
Identifier Source: org_study_id
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