Mechanisms for Individual Differences in Hypertension in Obstructive Sleep
Completed
Conditions studied: Sleep Apnea, Obstructive, Hypertension
In brief
Hypertension is a common consequence of obstructive sleep apnea (OSA). However, not all individuals with OSA have hypertension and there are major individual differences in blood pressure response to positive airway pressure treatment of OSA. This project is focused on determining the basis of these individual differences in blood pressure response to OSA and will evaluate the possible underlying reasons for these differences. The results will help clinicians to know whether or not to expect a reduction in blood pressure (BP) to OSA treatment in a given patient and thereby personalize patient management.
Key facts
- Study ID
- NCT03176732
- Run by
- University of Pennsylvania
- People needed
- 155
- Starts
- 2017-06-06
- Expected to finish
- 2022-06-30
- Last updated by the study team
- 2023-04-26
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age between 18 and 75 years
- Apnea-Hypopnea Index (AHI) ≥ 15 events/hr on diagnostic polysomnography(PSG)
- No previous history of surgical treatment of OSA, and no medical treatment of OSA within the past 6 months
- Adherence to prescribed anti-hypertensive medications as assessed by an average adherence between Visits 1-2 of at least 0.85
- Arm circumference less than 50 cm
You may not qualify if…
- Unable or unwilling to provide informed consent
- No telephone access or inability to return for follow-up
- Diagnosis of another sleep disorder in addition to OSA (e.g., periodic limb movement disorder [greater than 5 limb movements associated with arousal/hr of sleep], central sleep apnea [greater than 50% of apneas are central apneas], obesity hypoventilation syndrome, narcolepsy)
- Positive urine drug screen for any of the following: amphetamines, cocaine, opiates, barbiturates, benzodiazepines, phencyclidine (PCP), alcohol (ETOH), methadone (Visit 1)
- Requiring oxygen, bi-level positive airway pressure, or adaptive servo-ventilation for treatment of OSA
- Oxygen saturation < 87% for a period of 2 minutes during resting wakefulness during home sleep testing (HST) or PSG (Visit 2)
- Severe and inadequately controlled arterial hypertension (SBP greater than 180 mm Hg; diastolic BP greater than 110 mm Hg on 2 of 3 spot measurements on Visit 1)
- Participants with 24-hr SBP ≥ 140 mm Hg who are not on BP medications and participants on 4 or more BP medications with a 24-hr SBP < 135 mm Hg (Visit 2)
- A clinically unstable medical condition as defined by a change in medications in the previous month, including anti-hypertensive medications, or a new medical diagnosis in the previous 2 months (e.g., myocardial infarction, chronic heart failure, unstable angina, active infection, thyroid disease, depression or psychosis, cirrhosis, surgery, or cancer)
- Shift workers, individuals who regularly experience jet lag, or have irregular work schedules by history over the last 3 months
- Women who are pregnant or sexually active and of child-bearing age not using a form of contraceptive
- Routine consumption of > 2 alcoholic beverages/day Excessive use of caffeine (greater than 10 cups/day)
- Inability to communicate verbally or less than a 5th grade reading level
Where it is running
- University of Pennsylvania — Philadelphia, Pennsylvania, United States
- University of Iceland — Reykjavik, Iceland
Full record on ClinicalTrials.gov
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