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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 nights, <3 weeks apart completed within 1 month
Awards & highlights

ProSAT Trial Summary

This trial is testing whether a drug called propranolol can help people with obstructive sleep apnea by lowering glucose and free fatty acid levels during sleep, and preserving vascular function.

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.Check my eligibility
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.See study design
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.

ProSAT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I use CPAP regularly but am willing to stop for this study.
Select...
I have severe obstructive sleep apnea.

ProSAT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 nights, <3 weeks apart completed within 1 month
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 nights, <3 weeks apart completed within 1 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Free fatty acid (FFA, mmol/L)
Secondary outcome measures
Blood pressure, mmHg
Glucose (mg/dl)
Heart rate
+3 more

ProSAT Trial Design

3Treatment 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 7 PM, after dinner. Blood pressure will be measured before administration, at 11 PM, and 7 AM. They will sleep from 11 Pm to 7 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. This visit is part of both the PROSAT 1.0 and PROSAT 2.0 study.
Group II: CPAPActive Control1 Intervention
Subjects will be admitted to the clinical research unit. They will sleep wearing CPAP according to their usual home settings. Blood pressure will be measured before administration, at 11 PM, and 7 AM. They will sleep from 11 Pm to 7 AM. During sleep blood will be sampled from an indwelling IV for measurement of FFA, glucose, insulin, and triglycerides. This visit part of the PROSAT 1.0 study.
Group III: 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 7 PM, after dinner. Blood pressure will be measured before administration, at 11 PM, and 7 AM. They will sleep from 11 Pm to 7 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. This visit is part of both the PROSAT 1.0 and PROSAT 2.0 study.

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,239 Previous Clinical Trials
14,816,490 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,810 Previous Clinical Trials
47,290,610 Total Patients Enrolled
Jonathan C Jun, MDPrincipal InvestigatorJohns Hopkins University
1 Previous Clinical Trials
144 Total Patients Enrolled

Media Library

Propranolol (Beta Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT03049306 — Phase 2
Obstructive Sleep Apnea Research Study Groups: Placebo Oral Tablet, Propranolol Oral Tablet, CPAP
Obstructive Sleep Apnea Clinical Trial 2023: Propranolol Highlights & Side Effects. Trial Name: NCT03049306 — Phase 2
Propranolol (Beta Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03049306 — Phase 2
Obstructive Sleep Apnea Patient Testimony for trial: Trial Name: NCT03049306 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the risks associated with taking Propranolol Oral Tablet?

"Propranolol Oral Tablet, which is currently in Phase 2 trials, received a score of 2. This suggests that while there is some evidence suggesting the medication is safe, there is no data affirming that the drug is effective."

Answered by AI

Could I be a candidate for this medication research?

"The target population for this study are those who have obstructive sleep apnea and are aged 20 to 65. Around 36 patients are needed for the trial."

Answered by AI

What does Propranolol Oral Tablet help patients with the most?

"Propranolol Oral Tablet is often given to patients in order to lower their risk of cardiovascular mortality. Additionally, this medication can also help treat angina pectoris, myocardial infarction, and obstructive hypertrophic cardiomyopathy."

Answered by AI

Is this study still recruiting patients who wish to participate?

"Unfortunately, this clinical trial is no longer looking for new participants. The study was last updated on 8/24/2022 and originally posted on 2/15/2017. However, there are presently 311 trials actively recruiting participants with obstructive sleep apnea (osa) and 43 studies for Propranolol Oral Tablet actively enrolling participants."

Answered by AI

Are people of all ages welcome to participate in this research?

"In order to participate in this clinical trial, patients must be 20-65 years old. There are 60 other trials for patients who are younger than 20 and 283 for those who are older than 65."

Answered by AI

How many patients are participating in this clinical trial?

"Unfortunately, this particular study is not recruiting at the moment. The clinical trial was initially posted on February 15th, 2017 and last updated on August 24th, 2022. If you are interested in other studies, 311 studies for obstructive sleep apnea (osa) and 43 for Propranolol Oral Tablet are currently enrolling participants."

Answered by AI

Who else is applying?

What state do they live in?
Maryland
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
What site did they apply to?
Johns Hopkins Bayview Medical Center

Why did patients apply to this trial?

Need something better than a CPAC machine.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How many visits and how long for each visit?
PatientReceived no prior treatments
~0 spots leftby May 2024