Propranolol for Obstructive Sleep Apnea
(ProSAT Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJonathan C Jun, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Johns Hopkins University

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Jonathan C Jun, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

If you have already taken part in the 'Metabolic Impact of Intermittent CPAP' study, you must have shown a more than 10% increase in nighttime fat or sugar levels during CPAP.

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

I have severe obstructive sleep apnea.

Exclusion Criteria

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

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

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

Treatment Details

Interventions

Propranolol (Beta Blocker)

Trial OverviewThe 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.

Participant Groups

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.

Propranolol is already approved in Canada for the following indications: