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COMPLETEDPHASE2

Propranolol for Sleep Apnea Therapy

NCT03049306•Johns Hopkins University

Summary

The primary objective of this study is to test whether a beta blocker, propranolol, lowers the overnight heart rate sleep in obstructive sleep apnea (OSA) during CPAP withdrawal. The secondary objectives are to test whether propranolol influences sleep architecture, morning blood pressure, and vascular function including reactive hyperemia index (RHI) and a marker of arterial stiffness, augmentation index (AIX).

Detailed Description

The overnight heart rate is increased in patients with obstructive sleep apnea (OSA), reflecting excessive sympathetic nervous system activity which may lead to long-term adverse cardiovascular consequences. 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 examine the effect of drug on nocturnal heart rate, morning blood pressure, and vascular health outcomes

Eligibility

Age

20 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•History of OSA (AHI\>20, \>50% events obstructive)
•Accustomed to CPAP use, and willing to discontinue CPAP temporarily for the study.
•If the participant has already completed "Metabolic Impact of Intermittent CPAP" (NA\_00086830), they must have exhibited a \>10% increase in nocturnal FFA or glucose during CPAP

Exclusion Criteria

•Cardiovascular risks
•* Decompensated congestive heart failure
•* Atrial fibrillation, sick sinus syndrome, 2nd or 3rd degree heart block, pacemaker implantation, Wolff-Parkinson-White Syndrome (if not known, will check on a screening EKG)
•* Uncontrolled hypertension \> 170/110
•* History of postural hypotension.
•* Resting systolic pressure \<90 or heart rate \< 50 on screening visit
•Drug interactions - currently taking any of the following drugs. (Subjects on these medications are excluded from participation and will not have the drug in question discontinued for the purposes of participation in the study. )
•* Calcium channel blockers that reduce heart rate (diltiazem, verapamil, fendiline, gallopamil)
•* Sympatholytic drugs: any other beta blocker; clonidine, terazosin or doxazosin; reserpine
•* Anti-arrhythmic drugs: (e.g. amiodarone, sotalol, digoxin, quinidine, lidocaine, propafenone)
+18 more criteria

Locations (1)

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Key Dates

Start Date

February 15, 2017

Primary Completion Date

May 1, 2024

Completion Date

May 1, 2024

Last Updated

September 5, 2024

Enrollment

ACTUAL participants

Conditions

Obstructive Sleep Apnea

Interventions

Propranolol Oral Tablet

DRUG

Placebo Oral Tablet

DRUG

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 5, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Propranolol for Sleep Apnea Therapy

Inclusion Criteria

Exclusion Criteria

OSA Risk Level in Dental Patients and Correlation With Complications After General Anesthesia

Digital-supported Orofacial Myofunctional Therapy in OSA

Maridebart Cafraglutide Versus Placebo in Adult Participants With Obstructive Sleep Apnea on Positive Airway Pressure Therapy

A Cross-sectional Study Examining Adipose Tissue in Obstructive Sleep Apnea

Diaphragm Ultrasound İn Children With OSAS

BodySleep Algorithm for OSA Diagnosis in Children