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New treatment option for Obstructive Sleep Apnea
Official title Intermittent Hypoxia-initiated Plasticity in Humans: A Multi-pronged Therapeutic Approach to Treat Sleep Apnea and Overlapping Co-morbidities
ClinicalTrials.gov ID: NCT05558501
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 60
You may be able to join if
- 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...
- 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...
- 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...
- All participants will have normal lung function and a normal EKG with no or minimal alcohol consumption (\< 2 oz of alcohol/night).
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Detroit, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Detroit, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.