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Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling

NCT02948894 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-09-10

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Mandibular advancement device

an oral appliance (a dental device) for obstructive sleep apnea

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-12-31
Completion
2022-05-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02948894 on ClinicalTrials.gov