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Mild Intermittent Hypoxia for Sleep Apnea

This study is looking for people with Obstructive Sleep Apnea (OSA) to see if a treatment called Mild Intermittent Hypoxia (MIH) can help improve blood pressure and how blood vessels work. OSA is a common condition linked to heart and blood vessel problems. MIH involves breathing air with lower oxygen levels for short periods, followed by normal air. Researchers will compare MIH to a "sham" treatment where participants breathe regular compressed air. The study will measure changes in your blood pressure and microvascular function (how small blood vessels work) at 15 days, 4 weeks, and 8 weeks after treatment. You may be eligible if you are between 30 and 60 years old, have OSA, and meet certain body mass index (BMI) and oxygen desaturation criteria. The study aims to enroll 60 participants.

Study design
This is an interventional study comparing Mild Intermittent Hypoxia to a sham treatment. It plans to enroll 60 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in blood pressure and microvascular function at 15 days, 4 weeks, and 8 weeks after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05558501

Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities

Recruiting
PHASE1Ages 30–60InterventionalTreatment
VA Office of Research and Development
~60 participants
Updated 2025-12-04 on ClinicalTrials.gov
What's tested:Mild Intermittent HypoxiaSham MIH

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Blood Pressure
Measured over Change at 15 days, 4 and 8- weeks following treatment compared to baseline
+2 more outcomes measured

Conditions

Obstructive Sleep Apnea

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HypercholesterolemiaHypertensionObstructive Sleep ApneaPrediabetes

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Jason H Mateika, PhD MS BS · PRINCIPAL_INVESTIGATOR · John D. Dingell VA Medical Center, Detroit, MI

Who to contact

Jason H Mateika, PhD MS BS
[email protected]
(313) 576-4481 · ext. 64481
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Eligibility criteria

Inclusion

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).
Participants will be newly diagnosed and not previously treated with CPAP.
Participants will also be diagnosed with hypertension. Participants will either be untreated or will be treated unsuccessfully with a single prescribed medication for hypertension. Hypertension will be classified according to the American Heart Association 2018 criteria which includes an elevated systolic blood pressure in the range of 120-129 and a diastolic pressure less than 80 mmHg in addition to stage I and stage II hypertension defined by a systolic blood pressure greater than 130 mmHg and a diastolic pressure greater than 80 mmHg.
Participants will also be included if they are pre-diabetic (HbA1C: 5.7 - 6.4 %; fasting blood glucose: 100 - 125 mg/dL) and have cholesterol levels ranging from 200-239 mg/dL.
All participants will have normal lung function and a normal EKG with no or minimal alcohol consumption (\< 2 oz of alcohol/night).
Females will be studied at similar points in their menstrual cycle.

Exclusion

Participants with baseline blood pressure greater than 160/110 will be excluded from participation.
Participants on any medications, with the exception of a single prescribed medication for individuals with resistant hypertension.
Participants with any other known disease (e.g. pulmonary hypertension).
Participants using any sleep promoting supplements including melatonin.
Night shift workers or participants who recently travelled across time zones.
Pregnant females.

What this trial measures

  • Change in Blood PressureChange at 15 days, 4 and 8- weeks following treatment compared to baseline

    Blood pressure measures over 24 hours will be obtained. Blood pressure will be measured every 20 minutes beginning on Sunday at 6 AM and ending Monday at 6 AM. Participants will wear an actigraph (Actiwatch Spectrum, Respironics) and record their activities in a journal to determine the arousal state (i.e., active wakefulness, quiet wakefulness and sleep) associated with each blood pressure measurement. The data will be separated into active-awake, rest-awake and sleep based on the activity log and corresponding data from an actigraph watch. The average value of blood pressure in a healthy individual is 120/80 mmHg. In their participants with OSA, the investigators expect the blood pressure to be higher at baseline and decrease 15 days after treatment. The investigators also expect that this reduction will be maintained at 4 and 8-weeks following treatment.

  • Change in Microvascular Function (Maximal hyperemic Response)Change at 15 days, 4 and 8- weeks following treatment compared to baseline

    Microvascular reactivity associated with hyperemia induced by vascular occlusion will be determined by analyzing the maximal hyperemic response (MHR) of tissue saturation index (TSI) signal derived from near-infrared spectroscopy (NIRS) of the lateral gastrocnemius muscle of the non-dominant leg. The average value of TSI MHR of the NIRS signals in healthy individuals is 159±9 %. In their participants with OSA, the investigators expect these values to be lower at baseline and to increase 15 days after treatment. The investigators also expect that the increase will be maintained 4 and 8-weeks following treatment.

  • Change in Microvascular Function (Time to reach Maximal Hyperemic Response)Change at 15 days, 4 and 8- weeks following treatment compared to baseline

    Microvascular reactivity associated with hyperemia induced by vascular occlusion will be determined by analyzing the time to reach maximal hyperemic response (tM) of tissue saturation index (TSI) signal derived from near-infrared spectroscopy (NIRS) of the lateral gastrocnemius muscle of the non-dominant leg. The average value of tM TSI in healthy individuals is 39±5 s. In their participants with OSA, the investigators expect these values to be higher at baseline and to lower 15 days after treatment. The investigators also expect that the decrease will be maintained 4 and 8-weeks following treatment.