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Behavioral Intervention

Acute Intermittent Hypoxia for Traumatic Brain Injury

N/A

Recruiting

Led By Alicia Z Vose, Ph.D.

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Adults aged 21-80 years

A mild to moderate traumatic brain injury (TBI) confirmed by medical records

Must not have

Pre-existing hypoxic pulmonary disease

History of obstructive lung diseases such as chronic obstructive pulmonary disease (COPD) or significant asthma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre-intervention, 1 day after intervention block and 1-week post intervention

Summary

This trial aims to study the effects of breathing low oxygen air for a short period, known as acute intermittent hypoxia (AIH), on individuals with chronic mild-moderate traumatic brain injury (

Who is the study for?

This trial is for individuals with chronic mild to moderate traumatic brain injury (TBI) who may benefit from a new therapy. Participants should be stable and not have other medical conditions that could interfere with the study.

What is being tested?

The study tests if breathing low oxygen air in short bursts (Acute Intermittent Hypoxia or AIH) combined with special training can improve airway protection better than training alone after TBI, using a double-blind cross-over design.

What are the potential side effects?

Possible side effects of Acute Intermittent Hypoxia might include brief dizziness, headache, or shortness of breath during the low oxygen periods. The task-specific training is generally safe but may cause fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 80 years old.

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I have a confirmed mild to moderate brain injury.

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I can make my own medical decisions.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung condition that causes low oxygen levels.

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I have a history of serious lung problems like COPD or severe asthma.

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I have a neurological condition or severe psychiatric disorder.

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I have had head or neck cancer in the past.

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I have heart disease caused by reduced blood flow.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre-intervention, 1 day after intervention block and 1-week post intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre-intervention, 1 day after intervention block and 1-week post intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-intervention, 1 day after intervention block and 1-week post intervention for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Duration of laryngeal vestibule closure (dLVC)

Time to laryngeal vestibule closure (Time-to-LVC)

Secondary study objectives

Penetration-Aspiration Scale Scores

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: AIH + TSTActive Control2 Interventions

Participants will complete a 5-day intervention blocks where they receive daily AIH followed by task specific airway protection training 60 minutes after the AIH exposure. Each exposure involves a 1-minute delivery of low oxygen (9-11% inspired O2), followed by a 1.5-min interval of room air breathing (21% O2). This method of waiting 45-60 minutes after the delivery of AIH and prior to engaging in task-specific training/rehabilitation enables sufficient time to increase brain derived neurotrophic factor (BDNF) following AIH, thereby augmenting the impact of task-specific training.

Group II: Sham AIH + TSTPlacebo Group2 Interventions

Participants will complete a 5-day intervention blocks where they receive sham AIH followed by task specific airway protection training 60 minutes after the AIH sham exposure. Sham AIH will be delivered using methods identical to AIH, except a normoxic gas mixture (\~21% O2) will be delivered. The gas mixture with normoxic air will effectively serve as a sham.

0 / 8Eligibility criteria met