Study Purpose:
This project seeks to investigate the effects of a single acute intermittent hypoxia (AIH) session on respiratory and non-respiratory motor function and EMG (electromyography) activity on patients with ALS (amyotrophic lateral sclerosis) and healthy controls.Study Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis (ALS) , Neuromuscular Diseases
Study Type:
Interventional
Type of Intervention:
N/A
Intervention Name:
Acute Intermittent Hypoxia, Sham Acute Intermittent Hypoxia
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
Barbara K Smith, PT, PhD, University of Florida
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
University of Florida
Barbara K Smith, PT, PhD / email hidden; JavaScript is required / (352) 294-5315
Gainesville, Florida, 32611 United States
Full Study Summary:
Most ALS patients survive less than 5 years after diagnosis, and the main cause of death is respiratory failure. The investigators are interested in the therapeutic potential of acute intermittent hypoxia (AIH) for individuals with neuromuscular diseases, such as ALS. More than two decades of research indicates AIH elicits meaningful respiratory and non-respiratory motor recovery. Acute intermittent hypoxia (AIH) consists of alternating periods of breathing mildly hypoxic (lowered oxygen concentration) and normoxic (normal oxygen concentration) air.
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.
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.
Study Sponsor:
University of Florida
Estimated Enrollment:
56
Estimated Study Start Date:
10 / 01 / 2018
Estimated Study Completion Date:
07 / 01 / 2023
Posting Last Modified Date:
07 / 26 / 2022
Date Study Added to neals.org:
08 / 24 / 2018
Minimum Age:
21 Years
Maximum Age:
75 Years
Can participants use Riluzole?
Yes
Inclusion Criteria:- a healthy adult
- clinical diagnosis of ALS
- baseline FVC >60% predicted for age, sex and height.
Exclusion Criteria:
- pregnant
- 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.
UF Clinical Research Center | Recruiting
Gainesville, Florida
32610
United States
University of Florida | Recruiting
Gainesville, Florida
32611
United States