N/A N=29 Randomized Single-blind Treatment

Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease

Amyotrophic Lateral Sclerosis (ALS) · Neuromuscular Diseases

Bottom Line

View on ClinicalTrials.gov: NCT03645031 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2025

Primary outcome: Primary: Percent Change in Maximal Inspiratory Pressure (MIP) — 0.3; -3.1; -4.8; -5.0 percentage change in MIP from baseline

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acute Intermittent Hypoxia (Other); Sham Acute Intermittent Hypoxia (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: University of Florida
Primary completion: Jun 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in Maximal Inspiratory Pressure (MIP)	0.3; -3.1; -4.8; -5.0	—
PRIMARY Percent Change in Maximal Voluntary Grip Force	-8.2; -11.2; 14.5; 18.2	—
PRIMARY Percent Change in Sniff Nasal Inspiratory Pressure	2.5; 7.4; 4.9; 5.8	—
SECONDARY Percent Change in Minute Ventilation	5.7; -5.6; 19.5; 2.6	—
SECONDARY Occlusion Pressure (P0.1)	-0.80; -0.60; -0.83; -0.47	—
SECONDARY Percentage Change in Respiratory EMG Vector Magnitude	-24.5; 7.4; 179.8; 352.3	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03645031). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.