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A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling (CRESCENT)

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ClinicalTrials.gov Identifier: NCT04119999
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborators:
Ng Teng Fong General Hospital
National University Hospital, Singapore
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

Brief 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 device- drug-eluting MAD that the team is developing.


Condition or disease Intervention/treatment Phase
Hypertension,Essential Obstructive Sleep Apnea Device: Mandibular Advancement Device Device: Continuous Positive Airway Pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling
Actual Study Start Date : August 28, 2019
Estimated Primary Completion Date : August 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Active Comparator: CPAP
Continuous Positive Airway Pressure
Device: Continuous Positive Airway Pressure
Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people with OSA

Experimental: MAD
Mandibular Advancement Device
Device: Mandibular Advancement Device
Mandibular advancement device (MAD) has been a novel method in the management of snoring and OSA. For mild to moderate sleep apnea, MADs have been a boon. A guideline published by American Academy of Sleep Medicine stated that MAD was indicated as first-line therapy for mild OSA and a second-line therapy for moderate to severe OSA




Primary Outcome Measures :
  1. 24-hour mean BP (24MBP) [ Time Frame: 6 months ]
    Difference in 24-hour mean BP (24MBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age of at least 40 years
  2. Chinese (based on the Identity Card or other Identity Document if the subject is a non-Singapore citizen or permanent resident)
  3. Physician diagnosed essential hypertension, on at least 1 medication for BP control
  4. 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:

1. 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)

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119999


Contacts
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Contact: Junping Liu 67795555 junping_liu@nuhs.edu.sg
Contact: Venesa Loh 67795555 mdcljyv@nus.edu.sg

Locations
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Singapore
NUHS Cardiosleep research laboratory Recruiting
Singapore, Singapore
Contact: Junping Liu    67795555    junping_liu@nuhs.edu.sg   
Sponsors and Collaborators
National University, Singapore
Ng Teng Fong General Hospital
National University Hospital, Singapore
Investigators
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Principal Investigator: Chi-Hang Lee, MD National University, Singapore

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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT04119999     History of Changes
Other Study ID Numbers: Senior CSA
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: To be decided by steering committee

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chi-Hang Lee, National University, Singapore:
sleep
remodeling
blood pressure
trial
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Essential Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases