Obstructive Sleep Apnea Clinical Trial
— CRESCENTOfficial title:
A Cardiosleep Research Program on Obstructive Sleep Apnea, Blood Pressure Control and Maladaptive Myocardial Remodeling
Verified date | February 2024 |
Source | National University of Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 321 |
Est. completion date | February 15, 2024 |
Est. primary completion date | August 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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, or (e) age of 75 years or older. Exclusion Criteria: 1. Known OSA on treatment 2. Cheyne-Stokes breathing or predominantly central sleep apnea (>50%) 3. Known secondary hypertension: from renal (renal artery stenosis, chronic renal failure); endocrine (aldosterone excess, pheochromocytoma, cushing's syndrome, hyperthyroidism) or cardiac causes (aortic coarctation) 4. Contraindications to CMR: implantable devices, cerebral aneurysm clips, cochlear implants, renal impairment (GRF <30ml/min/1.73m2), claustrophobia and pregnant women 5. 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 6. Limited life expectancy (< 1 year) 7. Hypertensive crisis, acute coronary syndromes or acute heart failure in the past 30 days 8. Known AF (not suitable for CMR and affects remodelling analysis) |
Country | Name | City | State |
---|---|---|---|
Singapore | NUHS Cardiosleep research laboratory | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University of Singapore | National Heart Centre Singapore, National University Hospital, Singapore, Ng Teng Fong General Hospital |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Subgroup analysis | Prespecified subgroups include - Age, Gender, BMI, wrist circumference, AHI, ODI, ESS, DM, IHD, number of HT medicine, Device adherence | 6 months and 12 months | |
Primary | 24-hour mean BP (24MBP) | Difference in 24-hour mean BP (24MBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring. | 6 months | |
Secondary | 24-hour systolic BP (24SBP) | Difference in 24-hour systolic BP (24SBP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring. | 6 months and 12 months | |
Secondary | 24-hour pulse pressure (24PP) | Difference in 24-hour pulse pressure (24PP) between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring. | 6 months and 12 months | |
Secondary | Nocturnal dipping | Difference in prevalence of nocturnal dipping between the patients in the MAD and CPAP groups as determined by 24-hour ambulatory BP monitoring. | 6 months and 12 months | |
Secondary | Ectopic beat | Difference in prevalence of ectopic beats between the patients in the MAD and CPAP groups as determined by continuous ECG monitoring | 12 months | |
Secondary | Myocardial remodeling | Difference in LV and LA dimensions between the patients in the MAD and CPAP groups as determined by cardiac MRI | 12 months | |
Secondary | Epworth Sleepiness Scale (ESS) score | Difference in change in ESS score between the MAD and CPAP groups | 6 months and 12 months | |
Secondary | Sleep Apnea Quality of Life Index (SAQLI) | Difference in change in SAQLI score between the MAD and CPAP groups | 6 months and 12 months | |
Secondary | Functional Outcome of Sleep Questionnaire (FOSQ) | Difference in change in SAQLI score between the MAD and CPAP groups | 6 months and 12 months | |
Secondary | 36-Item Short Form Health Survey (SF-36) | Difference in change in SF-36 score between the MAD and CPAP groups | 6 months and 12 months | |
Secondary | EuroQol 5Q (EQ5D) | Difference in change in EQ5D score between the MAD and CPAP groups | 6 months and 12 months | |
Secondary | Daytime systolic BP | Difference in change in daytime systolic BP between the patients in the MAD and CPAP | 6 months and 12 months | |
Secondary | Nighttime systolic BP | Difference in change in nighttime systolic BP between the patients in the MAD and CPAP | 6 months and 12 months | |
Secondary | Percentage of patient with 24-hour systolic BP<130 mmHg | Difference in percentage of patients with 24-hour systolic BP<130 mmHg in the MAD and CPAP groups | 6 months and 12 months | |
Secondary | Percentage of patient with 24-hour systolic BP<120 mmHg | Difference in percentage of patients with 24-hour systolic BP<120 mmHg in the MAD and CPAP groups | 6 months and 12 months | |
Secondary | NT-proBNP | Change in the plasma level of NT-proBNP from baseline to 6-month follow-up | 6 months and 12 months | |
Secondary | High sensitivity troponin | Change in the plasma level of high sensitivity troponin from baseline to 6-month follow-up | 6 months and 12 months | |
Secondary | High sensitive C-reactive protein | Change in the plasma level of high sensitive C-reactive protein from baseline to 6-month follow-up | 6 months and 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05857384 -
Bioavailability, Bioequivalence and Tolerability of IHL-42X Compared to the Reference Drugs
|
Phase 1 | |
Recruiting |
NCT04547543 -
Follow-up of Apneic Patients by Visio-consultation
|
N/A | |
Recruiting |
NCT05371509 -
Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
|
N/A | |
Completed |
NCT02515357 -
Mediterranean Diet/Lifestyle Intervention in Obstructive Sleep Apnea
|
N/A | |
Completed |
NCT05582070 -
Effect on Sleep of Surgical Treatment of Severe Nasal Obstruction
|
N/A | |
Active, not recruiting |
NCT03189173 -
Combined Upper-airway and Breathing Control Therapies for Obstructive Sleep Apnea
|
Phase 2 | |
Completed |
NCT04084899 -
The Effect of CPAP on Lung Hyperinflation in Patients With OSA
|
||
Completed |
NCT03032029 -
Registry on the Treatment of Central and Complex Sleep-Disordered Breathing With Adaptive Servo-Ventilation
|
||
Recruiting |
NCT04028011 -
Clinical Evaluation of a Wearable Technology for the Diagnosis of Sleep Apnoea
|
||
Recruiting |
NCT06047353 -
Community Health Advocates for Motivating PAP Use in Our Neighborhoods.
|
N/A | |
Completed |
NCT05253963 -
Acute Effect of CPAP on Weight in Patients With Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT06029959 -
Stroke and CPAP Outcome Study 3
|
N/A | |
Recruiting |
NCT06150352 -
Sleep Apnea, Neurocognitive Decline and Brain Imaging in Patients With Subjective or Mild Cognitive Impairment
|
||
Completed |
NCT03589417 -
Postural Stability, Balance and Fall Risk in Patients With Obstructive Sleep Apnea
|
||
Recruiting |
NCT04335994 -
ENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing
|
N/A | |
Withdrawn |
NCT04063436 -
Evaluation of a New Nasal Pillows Mask for the Treatment of Obstructive Sleep Apnea
|
N/A | |
Recruiting |
NCT05385302 -
Sociological Determinants of Positive Airway Pressure Adherence in OSA Patients
|
||
Recruiting |
NCT04572269 -
Metabolomics of Obstructive Sleep Apnea
|
||
Not yet recruiting |
NCT06467682 -
12-week Tele-exercise Program in Patients With OSA
|
N/A | |
Withdrawn |
NCT04011358 -
Retinal Vein Occlusion and Obstructive Sleep Apnea: A Case Control Study
|
N/A |