Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling
MOSAIC
1 other identifier
interventional
100
1 country
2
Brief Summary
Primary aim: The MOSAIC trial aims to assess the impact of a mandibular advancement device (MAD) on Apnea-Hypopnea Index (AHI) in Asian patients with Heart Failure with reduced Ejection Fraction (HFrEF) and obstructive sleep apnea (OSA). The investigators hypothesize that the AHI was 60% lower after 3-month treatment with MAD than with sham MAD. Secondary aims: The investigators also aim to determine i. the interaction between ethnicity (Chinese, Malay, Indians) and the effects of MAD in lowering AHI; ii. the effect of MAD on cardiac remodeling (LVEDVI assessed by cardiac magnetic resonance imaging \[CMR\]); iii. the characteristic craniofacial skeletal anatomy (using coned beam computed tomography \[CT\]) associated with OSA in Asian patients with HFrEF; iv. the association between self-reported adherence to MAD and cardiac remodeling; v. the effects of MAD on biomarkers of HF (N-terminal pro-B-type natriuretic peptide \[NT-proBNP\],high sensitivity cardiac troponin T \[hs cTnT\], high-sensitivity C-reactive protein \[hs-CRP\], and ST2); Rationale: OSA is associated with incident HF. The investigators will study Asian patients because a body of evidence suggests mechanisms for OSA differ between Asians and Caucasians. While obesity is the major contributing factor in Caucasians, craniofacial skeletal anatomy (short mandible, maxilla, and cranial base and a large mandibular volume) plays an important role in the development of OSA among Asians. Using cone beam CT, it has been shown that Asians have shorter mandibular, maxillary, and cranial base lengths and a greater mandibular volume compared with Caucasians. Using a MAD to adjust maxillary-mandibular juxta-positioning to maintain a patent airway may be an ethnic-specific approach to treat OSA in Asians.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2018
Typical duration for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2016
CompletedFirst Posted
Study publicly available on registry
October 31, 2016
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2022
CompletedSeptember 10, 2020
September 1, 2020
2.7 years
October 27, 2016
September 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Apnea-Hypopnea Index
3 months
Secondary Outcomes (2)
cardiac remodeling (Left ventricular end diastolic volume index)
3 months
biomarkers of heart failure
3-months
Study Arms (2)
MAD
EXPERIMENTALMandibular advancement device. A dentist, who is otherwise not involved in HF care, will open a sealed envelope at the time of randomization and program the MAD device accordingly. Each mode will be maintained for 3 months
Sham-MAD
PLACEBO COMPARATORMandibular advancement device (non-advanced device). A dentist, who is otherwise not involved in HF care, will open a sealed envelope at the time of randomization and program the MAD device accordingly. Each mode will be maintained for 3 months
Interventions
an oral appliance (a dental device) for obstructive sleep apnea
Eligibility Criteria
You may qualify if:
- Asians (Chinese, Malay or Indians) living in Singapore
- Symptomatic HF (NYHA classes II-III) due to ischemic cardiomyopathy
- LVEF \<45% (as determined by echocardiography)
- Clinical stability for ≥1 month
- Optimal medical therapy including a diuretic, an angiotensin-converting enzyme inhibitor or an angiotensin receptor blocker, and a beta-blocker. The doses of these background medications should be stable for ≥1 month.
You may not qualify if:
- Known OSA on treatment
- Acute coronary syndrome within the preceding 3 months
- Severe valvular heart disease
- Sustained ventricular arrhythmia
- Stroke with residual neurological deficits
- Contraindication to CMRsuch as a pacemaker or cardioverter-defibrillator implant.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Chi-Hang Lee
Singapore, 119228, Singapore
Venesa Loh
Singapore, 119228, Singapore
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 27, 2016
First Posted
October 31, 2016
Study Start
May 1, 2018
Primary Completion
December 31, 2020
Study Completion
May 31, 2022
Last Updated
September 10, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will not share