What side effects are associated with this type of intervention?

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, oral appliances, and surgical interventions. CPAP therapy can cause side effects such as nasal congestion, dry mouth, and skin irritation from the mask. Oral appliances may lead to jaw discomfort and dental issues. Surgical treatments can result in pain, swelling, and infection risks. Beta-adrenergic receptor blockers like Propranolol, while not a standard treatment for OSA, are being studied for their potential benefits. Known side effects of beta-blockers include fatigue, dizziness, and bradycardia (slow heart rate).

What prior FDA approvals exist?

There are no specific FDA approvals for beta-adrenergic receptor blockers like Propranolol for the treatment of Obstructive Sleep Apnea (OSA). The primary treatments for OSA typically include lifestyle changes, continuous positive airway pressure (CPAP) therapy, oral appliances, and in some cases, surgery. Pharmacologic treatments are not commonly the first line of therapy for OSA, and there is limited evidence on the use of beta-blockers for this condition.

What other types of research exist?

Promising novel alternatives to Propranolol for Obstructive Sleep Apnea patients include: 1) Positive Airway Pressure (PAP) therapies, such as CPAP and BiPAP, which remain the gold standard for OSA management. 2) Hypoglossal nerve stimulation, which has shown efficacy in reducing OSA severity by stimulating the muscles of the upper airway. 3) Pharmacological agents like Solriamfetol, a wakefulness-promoting agent approved for excessive daytime sleepiness associated with OSA. 4) Weight loss medications and bariatric surgery for patients with obesity-related OSA. These alternatives target different aspects of OSA pathophysiology and may offer benefits over beta-blockade.

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Beta Blocker

Propranolol for Obstructive Sleep Apnea (ProSAT Trial)

Phase 2

Waitlist Available

Led By Jonathan C Jun, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Accustomed to CPAP use, and willing to discontinue CPAP temporarily for the study

History of OSA (AHI>20, >50% events obstructive)

Must not have

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

Other medical conditions: sleep disorder other than OSA, shift work or circadian rhythm disorder, insulin-dependent diabetes mellitus, myasthenia gravis, pheochromocytoma, uncontrolled bronchospastic lung disease, current smoking, chronic renal or liver failure, known pregnancy or nursing, known hypersensitivity to any beta blocker, history of falling asleep while driving, near miss, high-risk occupation, hemoglobin < 10 g/dL on point of care screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the morning after each intervention at 7:00 am (approximately 11.5 hours post administration for each intervention)

Summary

This trial tests whether propranolol can manage blood sugar and fat levels during sleep in people with sleep apnea who stop using their CPAP machines. Propranolol works by blocking stress signals that increase these levels, potentially improving heart health and metabolism.

Who is the study for?

This trial is for people who have been diagnosed with Obstructive Sleep Apnea (OSA), are used to using CPAP machines, and can stop using them temporarily. They should not have other sleep disorders, certain heart conditions, severe lung diseases, or be taking conflicting medications.

What is being tested?

The study aims to see if Propranolol helps lower blood sugar and fat levels during sleep in OSA patients compared to a placebo. It also looks at how it affects vascular function, sleep quality, and hemodynamics when CPAP is stopped.

What are the potential side effects?

Propranolol may cause side effects like low blood pressure, slow heartbeat, tiredness, dizziness upon standing up quickly due to its effect on the cardiovascular system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I use CPAP regularly but am willing to stop for this study.

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I have severe obstructive sleep apnea.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have serious heart conditions or uncontrolled high blood pressure.

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I do not have sleep disorders, diabetes, or severe lung, kidney, or liver issues.

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I am currently taking medication that may interact with the trial drug.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the morning after each intervention at 7:00 am (approximately 11.5 hours post administration for each intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the morning after each intervention at 7:00 am (approximately 11.5 hours post administration for each intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and the morning after each intervention at 7:00 am (approximately 11.5 hours post administration for each intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Nocturnal Heart Rate (Beats/Min, BPM)

Secondary study objectives

Augmentation Index (%)

Diastolic Blood Pressure (mmHg)

Reactive Hyperemia Index (RHI)

+1 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Propranolol Oral TabletActive Control2 Interventions

Subjects will be admitted to the clinical research unit. On the CPAP withdrawal nights, Propranolol LA (Inderal ® LA) 80 mg will be administered orally before sleep, at 6:30 PM, after dinner. Blood pressure will be measured before administration, at 10:30 PM, and 6:30 AM. They will sleep from 10:30 Pm to 6:30 AM. During sleep blood will be sampled from an indwelling IV for measurement of FFA, glucose, insulin, and triglycerides. This arm will be crossed-over to placebo 1 week later. This arm will is crossed-over with active drug 1 week before or after this study night.

Group II: Placebo Oral TabletPlacebo Group2 Interventions

Subjects will be admitted to the clinical research unit. On the CPAP withdrawal nights, placebo of propranolol LA (Inderal ® LA) 80 mg will be administered orally at 6:30 PM, after dinner. Blood pressure will be measured before administration, at 10:30 PM, and 6:30 AM. They will sleep from 10:30 PM to 6:30 AM. During sleep blood will be sampled from an indwelling IV for measurement of FFA, glucose, insulin, and triglycerides. This arm will is crossed-over with active drug 1 week before or after this study night.

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Obstructive Sleep Apnea (OSA) include Continuous Positive Airway Pressure (CPAP) therapy, which keeps the airway open by providing a constant stream of air through a mask, and oral appliances that reposition the jaw to maintain airway patency. Beta-adrenergic receptor blockers like propranolol, studied for their potential benefits in OSA, work by reducing sympathetic nervous system activity, which can lower blood pressure and heart rate, potentially improving sleep quality and cardiovascular outcomes. Understanding these mechanisms is crucial for OSA patients as it highlights the importance of maintaining open airways and managing cardiovascular risks associated with the condition.

Clinical course and prognosis of patients with typical and atypical hypertrophic obstructive and with hypertrophic non-obstructive cardiomyopathy.Effects of non-bronchoconstrictive doses of inhaled propranolol on airway responsiveness to methacholine.Migrainous central retinal artery occlusion.