Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities
Key facts
- Who runs it
- VA Office of Research and Development
- Where
- Detroit, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 1/2
- People taking part
- 60 people, planned
- Started
- 1 Jan 2023
- Expected to end
- 31 Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
- Treatments tested
- Mild Intermittent Hypoxia
- Sham MIH
- Record updated
- 4 December 2025
Who can take part
- Age
- 30 years to 60 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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 with baseline blood pressure greater than 160/110 will be excluded from participation
- Participants using any sleep promoting supplements including melatonin
- Night shift workers or participants who recently travelled across time zones
- Pregnant females
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 30 and 60 years old?
Where in United States
- John D. Dingell VA Medical Center, Detroit, MIDetroit, United StatesContact: Edi Levi, MDTaking people
About the trial
What the trial wants to find out
The prevalence of obstructive sleep apnea (OSA) is high in the United States and is a major health concern. This disorder is linked to numerous heart, blood vessel and nervous system abnormalities, along with increased tiredness while performing exercise likely because of a reduced blood supply to skeletal muscles. The gold standard treatment of OSA with continuous positive airway pressure (CPAP) in many cases does not lead to significant improvements in health outcomes because the recommended number of hours of treatment per night is often not achieved. Thus, development of novel treatments to eliminate apnea and lessen the occurrence of associated health conditions is important. The investigators will address this mandate by determining if repeated exposure to mild intermittent hypoxia (MIH) reduces heart and blood vessel dysfunction and tiredness/ fatigue experienced while exercise performance. The investigators propose that exposure to MIH has a multipart effect. MIH directly targets heart and blood vessel associated conditions, while simultaneously increasing upper airway stability and improving sleep quality. These modifications may serve to directly decrease breathing episodes and may also serve to improve usage of CPAP. Independent of its effect, MIH may serve as an adjunctive therapy which provides another path to reducing heart and blood vessel abnormalities that might ultimately result in improvements in exercise capacity and reverse performance fatigue in individuals with OSA.
The 2 groups in the trial
- Mild Intermittent Hypoxia (MIH)Treatment being tested
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.
Treatment: Mild Intermittent Hypoxia
- Sham Mild Intermittent Hypoxia (Sham MIH)Sham treatment, for comparison
This arm of the protocol will receive sham MIH (the equivalent of room air), while in the laboratory.
Treatment: Sham MIH
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Fit questions
- Built from NCT05558501, who can take part
- Record updated
- 4 December 2025