N/A
Completed N=29
Acute Intermittent Hypoxia and Breathing in Neuromuscular Disease
Amyotrophic Lateral Sclerosis (ALS) · Neuromuscular Diseases
Source: ClinicalTrials.gov NCT03645031 ↗
Enrolled (actual)
29
Serious AEs
0.0%
Results posted
May 2025
Primary outcomePrimary: Percent Change in Maximal Inspiratory Pressure (MIP) — 0.3; -3.1; -4.8; -5.0 percentage change in MIP from baseline
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.
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 | — |
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.
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. Informational only — not medical advice.