AzTrials
AzTrials

Obstructive Sleep ApneaPhase 2ProSATNCT03049306

Propranolol for Sleep Apnea Therapy

A Phase 2 study testing Propranolol Oral Tablet in people with Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Obstructive Sleep Apnea
What is being tested?
Propranolol Oral Tablet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteUnited States
Study dates
15 Feb 2017to 1 May 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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)
  • Coumadin (propranolol may prolong INR)
  • Drugs that Inhibit CYP2D6, CYP1A2, or CYP2C19: amiodarone, ciprofloxacin, cimetidine, delavirdine, fluconazole, fluoxetine, fluvoxamine, imipramine, isoniazid, paroxetine, quinidine, ritonavir, rizatriptan, teniposide, theophylline, tolbutamide, zileuton, zolmitriptan
  • Drugs that increase hepatic metabolism of propranolol: rifampin, ethanol, phenytoin, and phenobarbital
  • Neuroleptics/anxiolytics: (thioridazine, chlorpromazine - may increase propranolol level), haloperidol, valium
  • Illicit drugs such as cocaine or amphetamines.
  • Other medical conditions
  • Sleep disorder other than OSA, including: restless leg syndrome, parasomnia, or narcolepsy.
  • Shift work or circadian rhythm disorder that is expected to prevent good sleep as scheduled in the protocol
  • Insulin-dependent diabetes mellitus
  • Myasthenia gravis
  • Pheochromocytoma
  • Uncontrolled bronchospastic lung disease such as asthma or chronic obstructive pulmonary disease (COPD)
  • Current smoking
  • Chronic renal or liver failure
  • Known pregnancy, by urine testing in women of child-bearing age; nursing mothers
  • Known hypersensitivity to any beta blocker
  • History of falling asleep while driving, near miss
  • High risk occupation (pilot, commercial driver) Hemoglobin < 10 g/dL on point of care screening

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland, 21224

Other trials in United States

About this study

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).

Read the 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

Being tested
Propranolol Oral Tablet, Placebo Oral Tablet
Keywords
Obstructive sleep apnea, CPAP, Propranolol, Metabolism
Medical subject headings
Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Propranolol Oral TabletDrug

    Also called beta blocker

    Patients will receive Propranolol LA 80 mg PO at 7 PM before sleep (on CPAP withdrawal nights only)

  • Placebo Oral TabletDrug

    Also called placebo

    Patients will receive Placebo tablet at 7 PM before sleep (on CPAP withdrawal nights only)

Study groups in NCT03049306
Study groupRoleWhat they receive
Placebo Oral TabletPlacebo comparatorSubjects 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.
Receives: Drug: Propranolol Oral Tablet; Drug: Placebo Oral Tablet
Propranolol Oral TabletActive comparatorSubjects 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.
Receives: Drug: Propranolol Oral Tablet; Drug: Placebo Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nocturnal Heart Rate (Beats/Min, BPM)

    Average overnight heart rate (10:30 PM to 06:30 AM)

    Measured: 1 Night (approximately 4 hours post administration for each intervention), from 10:30 PM to 06:30 AM

Secondary outcomes (4)

  1. Reactive Hyperemia Index (RHI)

    Reactive Hyperemia Index (RHI) is measured by assessing the change in pulse wave amplitude in the brachial artery before and after a period of occlusion (usually 5 minutes). RHI is unitless as it reflects the ratio of pulse wave amplitude after : before occlusion. A high RHI indicates good endothelial function (values >1.67) and healthy vascular reactivity, while a low RHI (values <1.67) suggest endothelial dysfunction, which may be a risk factor for cardiovascular disease.

    Measured: The morning after each intervention at 7:00 AM (approximately 11.5 hours post administration for each intervention)

  2. Systolic Blood Pressure (mmHg)

    Measured in the morning (7 AM)

    Measured: The morning after each intervention at 7:00 AM (approximately 11.5 hours post administration for each intervention)

  3. Diastolic Blood Pressure (mmHg)

    Measured in the morning (7 AM)

    Measured: The morning after each intervention at 7:00 AM (approximately 11.5 hours post administration for each intervention)

  4. Augmentation Index (%)

    The Augmentation Index (AIx) is measured by analyzing the arterial pulse wave, which captures the pressure wave reflections in the arteries. A higher AIx indicates increased arterial stiffness and higher cardiovascular risk, while a lower AIx suggests more compliant, healthier arteries. AIx can theoretically range from negative values to over 100%, although clinical values usually are between -10% and +40%.

    Measured: The morning after each intervention at 7:00 AM (approximately 11.5 hours post administration for each intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2017
  2. Study start15 Feb 2017
  3. Primary completion1 May 2024
  4. Study completion1 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03049306
Sponsor's protocol ID
IRB00113241
Other IDs
1R03HL138068-01
Acronym
ProSAT
Status last verified
Aug 2024
First submitted
6 Dec 2016
Last updated
5 Sep 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pham LV, Duan D, Badami V, Perin J, Potocki M, Polotsky VY, Jun JC. Propranolol mitigates sleep apnea-related cardiac responses during CPAP withdrawal: a randomized placebo-controlled cross-over clinical study. Sleep Breath. 2026 Mar 11;30(1):88. doi: 10.1007/s11325-026-03645-8.

    PubMed 41811641

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Propranolol Oral Tablet in people with Obstructive Sleep Apnea, run by Johns Hopkins University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nocturnal Heart Rate (Beats/Min, BPM) (time frame: 1 Night (approximately 4 hours post administration for each intervention), from 10:30 PM to 06:30 AM). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03049306, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Propranolol for Sleep Apnea Therapy (NCT03049306) | AzTrials