N/A
N=12
Acute Intermittent Hypoxia in Traumatic Brain Injury
Brain Injuries, Traumatic
Bottom Line
View on ClinicalTrials.gov: NCT04890639 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Feb 2026
Primary outcome: Primary: Change in Vitals at Visit 2 — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Acute Intermittent Hypoxia (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shirley Ryan AbilityLab
- Primary completion
- Jan 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Vitals at Visit 2 |
— | — |
| PRIMARY Change in Vitals at Visit 3 |
— | — |
| PRIMARY Change in Vitals at Visit 4 |
— | — |
| PRIMARY Change in Vitals at Visit 5 |
— | — |
| PRIMARY Change in Symptoms at Visit 2 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change in Symptoms at Visit 3 |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Change in Symptoms at Visit 4 |
0; 0; 2; 0; 0; 0 | — |
| PRIMARY Change in Symptoms at Visit 5 |
0; 0; 1; 0; 0; 0 | — |
| SECONDARY Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) Scores |
98.83; 102.33; 97.17; 93.50; 106.17; 101.25 | — |
| SECONDARY California Verbal Learning Test (CVLT-II) Scores |
48.25; 50.33; 10.75; 11.50; 12.00; 12.17 | — |
| SECONDARY D-KEFS (Delis-Kaplan Executive Function System) Verbal Fluency Test Scores |
51.58; 46.67; 46.50; 46.50; 13.83; 13.17 | — |
| SECONDARY Serial Reaction Time Task (SRTT) Scores |
0.11; 0.04 | — |
| SECONDARY Trail Making Test (TMT) Scores |
22.36; 22.82; 56.55; 47.09 | — |
| SECONDARY Finger Tapping Test Scores |
48.55; 52.31; 53.69; 55.89; 56.95; 58.12 | — |
| SECONDARY Grooved Pegboard Test Scores |
68.90; 60.80; 60.80; 61.40; 57.80; 58.80 | — |
| SECONDARY Rey Auditory Verbal Learning Test (RAVLT) Scores |
51.92; 61.83; 66.92; 69.00; 9.83; 12.33 | — |
| SECONDARY Beck Depression Inventory (BDI-II) Scores |
7.42; 5.42 | — |
| SECONDARY Visual Analogue Mood Scale (VAM-S) Scores |
72.3; 69.8; 77.2; 71.4 | — |
| SECONDARY Motor Evoked Potentials (MEPs) |
1625.13; 1179.86 | — |
| SECONDARY MRI |
— | — |
Summary
This study is designed to answer questions related to safety and preliminary efficacy of Acute Intermittent Hypoxia (AIH) in Traumatic Brain Injury (TBI) survivors. First, we aim to establish whether brief reductions in inhaled oxygen concentration can be safely tolerated in TBI survivors. Second, we aim to establish whether there are any effects of AIH on memory, cognition, and motor control. Participants will be monitored closely for any adverse events during these experiments. Data will be analyzed to determine if there is an improvement in key outcomes at any dose level.
Eligibility Criteria
Inclusion Criteria
- Aged 18-65 years
- A first time, mild to moderate traumatic brain injury (TBI) confirmed by medical records
- When available, a Glasgow Coma Scale score between 9-15
- Able to use a keyboard
- Able to understand and communicate in English
- Able to consent independently
- Able to leave a research visit with a companion/group transportation
- Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study
- Not involved in any other research intervention study testing neurobehavioral functioning
Exclusion Criteria
- Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability
- Severe aphasia, preventing a participant from understanding the protocol and consent form
- Pre-existing hypoxic pulmonary disease
- Severe hypertension (>160/100)
- Medically documented history of obstructive lung diseases [e.g., Chronic obstructive pulmonary disease (COPD) or significant asthma]
- Ischemic cardiac disease
- Ineligible to undergo MRI or TMS
Data sourced from ClinicalTrials.gov (NCT04890639). 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.