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Mild Intermittent Hypoxia for Sleep Apnea and Spinal Cord Injuries

This study is looking at how mild intermittent hypoxia (brief periods of reduced oxygen) might help people with obstructive sleep apnea (OSA) and spinal cord injuries. Researchers believe that repeated, mild exposure to reduced oxygen could strengthen the muscles in your upper airway, potentially making your continuous positive airway pressure (CPAP) treatment more effective and easier to use. You would receive either mild intermittent hypoxia or a sham protocol (breathing room air) for 3 weeks, 5 days a week, in addition to using CPAP every night. The study will measure changes in your blood pressure to see if this approach is helpful. To join, you need to be 18-60 years old, have newly diagnosed sleep apnea, and have prehypertension or Stage 1 hypertension. The study aims to enroll 40 participants.

Study design
This is an interventional study with 40 planned participants. You would be randomly assigned to receive either mild intermittent hypoxia or a sham protocol.
What's involved
You would receive either mild intermittent hypoxia or a sham protocol for twelve two-minute episodes, 5 days a week for 3 weeks. All participants will also use CPAP every night for 3 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your blood pressure will be measured before and after 15 days of exposure to the study protocols.

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

NCT03736382

Mild Intermittent Hypoxia and Its Multipronged Effect on Sleep Apnea

UNKNOWN
NAAges 18–60InterventionalTreatment
Wayne State University
~40 participants
Updated 2024-07-19 on ClinicalTrials.gov
What's tested:Mild intermittent hypoxiaSham protocolContinuous positive airway pressure (CPAP)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in blood pressure measured during quiet wakefulness over the 24 hour period following mild intermittent hypoxia and sham protocol
Measured over Before and after 15 days of exposure to mild intermittent hypoxia or a sham protocol.

Conditions

Obstructive Sleep Apnea
Spinal Cord Injuries

Explore related trials

Obstructive Sleep ApneaSpinal Cord Injury

Where it's being run

2 sites across 1 states
Michigan2

Study leadership

  • Jason H Mateika, Ph.D. · PRINCIPAL_INVESTIGATOR · Wayne State University

Who to contact

Jason H Mateika, Ph.D.
[email protected]
313-576-4481
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Body mass index \< 40 kg/m\^2.
18 to 60 years old.
Newly diagnosed sleep apnea (i.e. apnea/hypopnea index \< 100 events per hour - average nocturnal oxygen saturation \> 85 %) that has not been treated.
Diagnosed with prehypertension or Stage 1 hypertension as categorized by the American Heart Association
Not pregnant.
Normal lung function.
Minimal alcohol consumption (i.e. no more than the equivalent of a glass of wine/day)
A typical sleep/wake schedule (i.e. participants will not be night shift workers or have recently travelled across time zones).
For spinal cord injured participants (Aim-2): incomplete spinal cord lesions at C3 or below and above T12 (greater than 36 mos. post-SCI) without joint contractures but with signs of voluntary ankle, knee and hip movements and the ability to ambulate at least one step without human assistance.

Exclusion

Any disease other than high blood pressure and sleep apnea.
Medications for high blood pressure and sleep promoting supplements including melatonin
Current effective CPAP usage (greater than 4 hours per night).
Night Shift workers or recently traveled across time zones.

What this trial measures

  • Change in blood pressure measured during quiet wakefulness over the 24 hour period following mild intermittent hypoxia and sham protocolBefore and after 15 days of exposure to mild intermittent hypoxia or a sham protocol.

    24 hour blood pressure measures will be obtained prior to the beginning and at the end of protocol to quantify blood pressure changes following mild intermittent hypoxia.