Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease

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.

Disease:

Amyotrophic Lateral Sclerosis (ALS), Familial ALS, Sporadic ALS, Healthy Volunteer, Healthy Volunteer with a Family History of ALS

Study Type:

Interventional Trial

Study Category:

Study Status:

Enrolling

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Barbara K Smith, PT, PhD, University of Florida

Clinicaltrials.gov ID (11 digit #):

NCT03645031

Neals Affiliated?

Coordinating Center Contact Information

University of Florida
Barbara K Smith, PT, PhD / .(JavaScript must be enabled to view this email address) / 352-294-5315
Jessica Ehrbar, MS / .(JavaScript must be enabled to view this email address) / 352-273-6855
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.

Study Sponsor:

University of Florida

Participant Duration:

Estimated Enrollment:

Estimated Study Start Date:

10/01/2018

Estimated Study Completion Date:

06/30/2021

Posting Last Modified Date:

07/29/2020

Date Study Added to alsconsortium.org:

12/14/2018

Eligibility Criteria

Gender:
Female, Male
Minimum Age:
30
Maximum Age:
65
Min Vital Capacity (% predicted normal):
50

Time since Symptom Onset:

Time since Diagnosis:

Can participants use Riluzole?
Yes

Inclusion Criteria:

a healthy adult
clinical diagnosis of ALS
baseline FVC >50% predicted for age, sex and height.

Exclusion Criteria:

pregnant
diagnosed cardiovascular disease
a BMI >30 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.
Site Contact Information

UF Clinical Research Center
Gainesville, Florida 32610
United States

University of Florida
Gainesville, Florida 32611
United States