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Mild Intermittent Hypoxia for Obstructive Sleep Apnea

Phase 1 & 2

Recruiting

Led By Jason H Mateika, PhD MS BS

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

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

Must have

Male or female of any race, 30-60 years of age with a BMI of less than 40 kg/m2 and a weight to hip ratio of less than 1.3in males and 1.2 in females along with pure or predominantly (i.e., comprised of both a central and obstructive component)OSA (AHI less than or equal to 100 events per hour and an average oxygen desaturation level of 85 % or greater).

All participants will have normal lung function and a normal EKG with no or minimal alcohol consumption (< 2 oz of alcohol/night).

Must not have

Participants with any other known disease (e.g. pulmonary hypertension)

Participants on any medications, with the exception of a single prescribed medication for individuals with resistant hypertension

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change at 15 days, 4 and 8-weeks following treatment compared to baseline

Summary

This trial will study if repeated exposure to mild intermittent hypoxia (MIH) can reduce heart and blood vessel dysfunction and tiredness/fatigue experienced while exercising for people with obstructive sleep apnea (OSA).

Who is the study for?

This trial is for adults aged 30-60 with a BMI under 40, newly diagnosed obstructive sleep apnea (OSA), and hypertension. They must have normal lung function, EKG readings, controlled alcohol intake, and not be on CPAP treatment or multiple medications. Pre-diabetic individuals with specific cholesterol levels can join too.

What is being tested?

The study tests whether mild intermittent hypoxia (MIH) can improve heart health and reduce fatigue during exercise in OSA patients by increasing airway stability and enhancing sleep quality. It compares MIH to a sham procedure to see if it's an effective standalone or adjunct therapy.

What are the potential side effects?

Potential side effects are not explicitly listed but may include discomfort from the hypoxia exposure or placebo effect from the sham procedure. The intervention aims to be minimally invasive.

Eligibility Criteria

Inclusion Criteria

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

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I am 30-60 years old, with a BMI under 40, and have sleep apnea with specific measurements.

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My lungs work normally, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol nightly.

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I have never used a CPAP machine before.

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I have never used CPAP for my condition before.

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I am between 30-60 years old, with a BMI under 40, and have sleep apnea with specific severity.

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My lung function is normal, my heart's electrical activity is normal, and I drink less than 2 oz of alcohol per night.

Exclusion Criteria

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

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I have a known disease such as pulmonary hypertension.

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I am only on one medication for high blood pressure that's hard to control.

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I use sleep aids like melatonin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change at 15 days following treatment compared to baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change at 15 days following treatment compared to baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and change at 15 days following treatment compared to baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Blood Pressure

Hyperemia

Change in Microvascular Function (Time to reach Maximal Hyperemic Response)

Secondary study objectives

Change in Fatigability

Change in Maximal Oxygen Consumption

Body Weight Changes

+4 more

Other study objectives

Change in Arousal Threshold

Continuous Positive Airway Pressure

Change in Sleep Apnea Severity

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Mild Intermittent Hypoxia (MIH)Experimental Treatment1 Intervention

This arm of the protocol will receive mild intermittent hypoxia (8% oxygen) with end-tidal carbon dioxide maintained 2 millimeters of mercury above baseline, while in the laboratory.

Group II: Sham Mild Intermittent Hypoxia (Sham MIH)Placebo Group1 Intervention

This arm of the protocol will receive sham MIH (the equivalent of room air), while in the laboratory.

0 / 9Eligibility criteria met