A Cardiosleep Research Program on Obstructive Sleep Apnea Blood Pressure Control and Maladaptive Myocardial Remodeling

  • STATUS
    Recruiting
  • End date
    Mar 21, 2024
  • participants needed
    400
  • sponsor
    National University, Singapore
Updated on 21 February 2021
continuous positive airway pressure
hypertension
stroke
chronic kidney disease
mandibular advancement
polysomnography
oral appliances

Summary

The objective of this proposal is to evaluate whether mandibular advancement device (MAD) is non-inferior to continuous positive airway pressure (CPAP) in the treatment of obstructive sleep apnea (OSA) and blood pressure reduction. OSA and hypertension are highly prevalent disorders with profound impacts on health. Apart from improving quality of-life, an effective OSA treatment could improve cardiovascular risk partly through blood pressure reduction, particularly in patients with high cardiovascular risk in whom blood pressure control is often suboptimal. Although CPAP is useful, the high non-acceptance and non-adherence preclude its widespread use.

East Asians have a restrictive craniofacial phenotype that predisposes them to OSA and the associated cardiovascular stress. CPAP, while considered the first-line therapy for OSA, has failed to improve cardiovascular outcomes in randomized trials till date because it is poorly tolerated. MADs are oral appliances that correct the restrictive craniofacial phenotype present in East Asians by protruding the lower jaw to reduce upper airway collapsibility. MADs are better tolerated than CPAP, and this may be an important determinant of the overall effectiveness in treating OSA, and thus ameliorating the downstream adverse health outcomes. We hypothesize that MADs are non-inferior to CPAP in treating OSA and reducing cardiovascular risk by blood pressure reduction in East Asians.

We will recruit East Asian subjects with hypertension and high cardiovascular risk for polysomnography. Patients diagnosed with OSA (n=220) will be randomized to MAD or CPAP groups in a 1:1 ratio for a treatment duration of 6 months. The primary endpoint is the 24-hour mean blood pressure as determined by ambulatory monitoring. The secondary endpoints include sleep-time systolic BP, target blood pressure, cardiovascular biomarkers, and myocardial remodeling. Association between OSA and silent paroxysmal atrial fibrillation will also be determined. If MADs are shown to be effective, the next step is to evaluate our novel devicedrug -eluting MAD that the team is developing.

Details
Condition Obstructive sleep apnea, Essential Hypertension, Primary Hypertension, Hypertension,Essential, obstructive sleep apnoea, obstructive sleep apnea syndrome
Treatment Mandibular advancement device, Continuous positive airway pressure
Clinical Study IdentifierNCT04119999
SponsorNational University, Singapore
Last Modified on21 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Age of at least 40 years
Chinese (based on the Identity Card or other Identity Document if the subject is a non-Singapore citizen or permanent resident)
Physician diagnosed essential hypertension, on at least 1 medication for BP control
High cardiovascular risk, as defined by one or more of the following: (a) diabetes mellitus, (b) stroke, (c) significant coronary artery disease (at least one stenosis of >50% diameter in at least one major epicardial artery), (d) chronic kidney disease, excluding polycystic kidney disease, with an estimated glomerular filtration rate of <60 ml/min/1.73m2, (e) 10-year risk of cardiovascular disease of 15% or greater on the basis of the Framingham risk score, or (f) age of 75 years or older.64 (modified from ref 64)

Exclusion Criteria

Known OSA on treatment 2. Severe excessive daytime sleepiness with Epworth sleepiness scale > 16/24 3. Increased risk of an accident from falling asleep (e.g. large, heavy vehicle drivers) 4. Severe hypoxemia - <80% for >10% of recording time 5. Cheyne-Stokes breathing or predominantly central sleep apnea (>50%) 6. Known secondary hypertension: from renal (renal artery stenosis, chronic renal failure); endocrine (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism) or cardiac causes (aortic coarctation) 7. Contraindications to CMR: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and pregnant women 8. Contraindications to MAD: <6 to 10 teeth in each arch, inability to advance the mandible and open the jaw widely, pre-existing temporomandibular joint problems, severe bruxism 9. Limited life expectancy (< 1 year) 10. Hypertensive crisis, acute coronary syndromes or acute heart failure in the past 30 days 11. Known AF (no suitable for CMR and affects remodelling analysis)
\-
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note