Using mild intermittent hypoxia to treat sleep apnea and related health issues
Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities
This study is testing if a new treatment using mild oxygen deprivation can help veterans with sleep apnea and high blood pressure feel better and stick to their current treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 30 Years to 60 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Detroit, Michigan) |
| Trial ID | NCT05558501 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of mild intermittent hypoxia (MIH) on patients with obstructive sleep apnea (OSA) and associated health conditions, particularly in the Veteran population. The study aims to determine if repeated exposure to MIH can improve cardiovascular and metabolic outcomes, as well as enhance adherence to existing treatments like CPAP. Participants will be newly diagnosed with OSA and hypertension, and the trial will assess the impact of MIH on blood pressure and microvascular function over time. The approach combines innovative therapy with traditional treatment methods to potentially yield better health outcomes.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 30-60 with a BMI under 40, diagnosed with obstructive sleep apnea and hypertension.
Not a fit: Patients who have previously been treated with CPAP or those with severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve health outcomes for patients with obstructive sleep apnea and related comorbidities.
How similar studies have performed: While some studies have explored the effects of intermittent hypoxia, this specific approach combining MIH with CPAP is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Detroit, Michigan
- John D. Dingell VA Medical Center, Detroit, MI — Detroit, Michigan, United States (Recruiting)
Study contacts
- Principal investigator: Jason H Mateika, PhD MS BS — John D. Dingell VA Medical Center, Detroit, MI
- Study coordinator: Jason H Mateika, PhD MS BS
- Email: jmateika@med.wayne.edu
- Phone: (313) 576-4481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.