Clinical trial NCT03645031: Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
Official title: Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amyotrophic Lateral Sclerosis (ALS)
Neuromuscular Diseases
Keywords: acute intermittent hypoxia (AIH)
respiratory motor function
hypoxia
normoxia
EMG (electromyography)
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will complete both the AIH and the sham AIH visits. The order of these visits will be randomized, but all subjects will complete both visits in the course of the study.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Percent Change in Maximal Inspiratory Pressure (MIP)
timeFrame: 3 Hours
measure: Percent Change in Maximal Voluntary Grip Force
timeFrame: 3 Hours
measure: Percent Change in Sniff Nasal Inspiratory Pressure
timeFrame: 3 Hours
Secondary outcomes:
measure: Percent Change in Minute Ventilation
timeFrame: 3 Hours
measure: Occlusion Pressure (P0.1)
timeFrame: 3 Hours
measure: Percentage Change in Respiratory EMG Vector Magnitude
timeFrame: 3 Hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Barbara K Smith, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: