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Clinical Trial Summary

The primary objective in this study is to test whether propranolol lowers glucose and free fatty acid levels during sleep in obstructive sleep apnea (OSA), and preserves vascular function (EndoPAT) versus placebo. The secondary objective is to test whether propranolol influences sleep quality, architecture, and hemodynamics in OSA. OSA will be elicited by temporarily discontinuing CPAP therapy in patients with a history OSA accustomed to CPAP therapy (CPAP withdrawal).


Clinical Trial Description

Free fatty acids and glucose elevations occur during the night in obstructive sleep apnea (OSA) patients, and these elevations may be responsible for adverse cardio-metabolic consequences of OSA. The sympathetic nervous system is well known to mediate adipose tissue lipolysis as well as "stress hyperglycemia". Thus, investigators may be able to mitigate these nocturnal metabolic changes with beta adrenergic blockade. Propranolol is a non-selective beta blocker that is used for a variety of indications including hypertension and anxiety. In this study investigators will administer propranolol or placebo to patients with OSA before sleep. Investigators will compare nocturnal metabolic profiles and hemodynamics on/off propranolol in the setting of CPAP withdrawal. This study involves 3 visits, one visit on CPAP and the other 2 visits after CPAP withdrawal. Propranolol or placebo is given during the CPAP withdrawal visits. A sub-study called "PROSAT 2" examines whether propranolol prevents changes in blood pressure, heart rate, and blood flow during sleep. PROSAT 2 involves only 2 visits, both after CPAP withdrawal. Propranolol or placebo is given during the CPAP withdrawal visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03049306
Study type Interventional
Source Johns Hopkins University
Contact
Status Enrolling by invitation
Phase Phase 2
Start date February 15, 2017
Completion date May 1, 2024

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