Brief low-oxygen breathing sessions for people with obstructive sleep apnea

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults newly diagnosed with obstructive sleep apnea who also have high blood pressure. It tests repeated short periods of breathing air with less oxygen.

Age

30 to 60 years

Sex

Men and women

Disease stage

Pure or mostly obstructive sleep apnea, AHI (breathing pauses per hour) of 100 or less, average oxygen level of 85 % or greater. High blood pressure: elevated (systolic 120-129, diastolic under 80 mmHg) or stage I or II. BMI under 40 kg/m2. Waist-to-hip ratio under 1.3 in men and 1.2 in women. Normal lung function and normal EKG.

Earlier treatment

No previous CPAP treatment. High blood pressure untreated, or treated without success with one prescribed medicine.

Biomarker or test result

People with prediabetes (HbA1C 5.7 - 6.4 % (39–46 mmol/mol); fasting blood sugar 100 - 125 mg/dL (5.6–6.9 mmol/L)) and cholesterol of 200-239 mg/dL (5.2–6.2 mmol/L) can also join.

Main reasons for not taking part

• Blood pressure above 160/110 at the start
• Taking any medicine, except one prescribed blood pressure medicine
• Any other known disease, such as pulmonary hypertension
• Using sleep aids such as melatonin, night shift work or recent travel across time zones
• Pregnancy, or drinking 2 oz of alcohol a night or more

The registry criteria, word for word

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?YesNo

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