Trial results for a study investigating acute intermittent hypoxia (AIH) in stroke patients were posted on ClinicalTrials.gov on 2026-04-07, involving 16 participants.
Background
Stroke affects 795,000 people annually in the US, with only a small percentage achieving full recovery. Current therapies focus on strength and endurance, but do not directly target the brain's capacity for reorganization after injury. This study explored acute intermittent hypoxia (AIH), a novel therapy involving brief periods of reduced oxygen levels via a face mask, known to trigger the release of specific substances.
Trial design
This completed study, designated as Phase NA, enrolled 16 participants with Stroke. The trial investigated acute intermittent hypoxia (AIH), where individuals received brief bouts of reduced oxygen levels through a face mask. No comparator arms were detailed in the posted results, and primary outcomes were not specified.
Key results
The trial reported several key measurements for the Hypoxia group:
- Number of Participants With Adverse Events: Counts of 1, 11, 2, 10, 1, and 11 participants were reported.
- National Institute of Health Stroke Scale (NIHSS) (Change in score on scale): A mean change of -0.3 (Standard Deviation 1.9) was observed.
- Fugl- Meyer Assessment (Change in score on a scale): A mean change of -1.6 (Standard Deviation 4.7) was observed.
- Modified Ashworth Scale (Change in score on a scale): A mean change of -0.1 (Standard Deviation 0.7) was observed.
- Grip Strength (Change in Pounds): Mean changes of 4.38 (Standard Deviation 7.6) and 1.6 (Standard Deviation 10.8) were reported.
- Pinch Strength (Change in Pounds): A mean change of 1.7 (Standard Deviation 3.5) was observed.
What this means
The posted results from this small, completed study provide initial safety and functional outcome data for acute intermittent hypoxia in stroke patients. While adverse events were reported, the observed mean changes in functional scales such as NIHSS, Fugl-Meyer Assessment, Modified Ashworth Scale, Grip Strength, and Pinch Strength were generally small, with some indicating a decrease or minimal change, and accompanied by notable standard deviations. Without comparative data or statistical analyses, the clinical significance of these changes remains unclear. This preliminary data may inform the design of future, larger studies.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT04019522, titled "American Heart Association- Stroke/Hypoxia Study", were posted on 2026-04-07 on clinicaltrials.gov.