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

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ClinicalTrials.gov Identifier: NCT02948894
Recruitment Status : Recruiting
First Posted : October 31, 2016
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
Chi-Hang Lee, National University, Singapore

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.


Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Heart Failure Device: Mandibular advancement device Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Mandibular Advancement Device for Treatment of Obstructive Sleep Apnea and Its Impact on Cardiac Remodeling
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
Experimental: MAD
Mandibular 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
Device: Mandibular advancement device
an oral appliance (a dental device) for obstructive sleep apnea

Placebo Comparator: Sham-MAD
Mandibular 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
Device: Mandibular advancement device
an oral appliance (a dental device) for obstructive sleep apnea




Primary Outcome Measures :
  1. Apnea-Hypopnea Index [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. cardiac remodeling (Left ventricular end diastolic volume index) [ Time Frame: 3 months ]
  2. biomarkers of heart failure [ Time Frame: 3-months ]
    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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT02948894


Locations
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Singapore
Chi-Hang Lee Recruiting
Singapore, Singapore, 119228
Contact: Lee Chi-Hang Ronald, MD    67722493 ext 22493    ronald_lee@nuhs.edu.sg   
Venesa Loh Recruiting
Singapore, Singapore, 119228
Contact: Venesa Loh    67795555    vlohjy@gmail.com   
Sponsors and Collaborators
National University, Singapore

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Responsible Party: Chi-Hang Lee, Associate Professor, National University, Singapore
ClinicalTrials.gov Identifier: NCT02948894    
Other Study ID Numbers: CG2020
First Posted: October 31, 2016    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases