Evidence map›Paper›PMID 22993169›Full record

Trial reportThorax2013

Objective measurement of compliance during oral appliance therapy for sleep-disordered breathing.

Olivier M Vanderveken, Marijke Dieltjens, Kristien Wouters, Wilfried A De Backer, Paul H Van de Heyning, Marc J Braem

Registry-linked trialAbstract readClinical TrialComparative Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Thorax, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02885571 (Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients), which is not on this map. Cited by 102 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
102citing papers in PubMed, 9 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02885571 naterminatednot on this mapstarted 2016, after this paper: background citation

Can Objective Compliance Monitoring Increase Mandibular Advancement Device Usage in Obstructive Sleep Apnea Patients

TypeinterventionalSponsorSeoul National University HospitalRan2016 to 2017Enrolled38ConditionsObstructive Sleep ApneaArmsSomnoDent Flex with DentiTrac
3 · Its place in the literature

Who cites it

102 citing papers in PubMed, 9 syntheses or guidelines pooled it.

  1. Oral appliances for obstructive sleep apnoea in adults.The Cochrane database of systematic reviews · 2026
    Pooled it
  2. Pooled it
  3. Factors influencing adherence to oral appliance therapy in adults with obstructive sleep apnea: a systematic review and meta-analysis.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
    Pooled it
  4. Pooled it
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  7. Anatomically Based Outcome Predictors of Treatment for Obstructive Sleep Apnea with Intraoral Splint Devices: A Systematic Review of Cephalometric Studies.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2015
    Pooled it
  8. Guideline
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  13. Mandibular advancement device treatment and reverse left ventricular hypertrophic remodeling in patients with obstructive sleep apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2022
    Trial
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  15. Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019
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  19. Ready-Made Versus Custom-Made Mandibular Repositioning Devices in Sleep Apnea: A Randomized Clinical Trial.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2017
    Trial
  20. Trial

42 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Olivier M VandervekenDepartment of Otolaryngology and Head and Neck Surgery, Antwerp University Hospital, Antwerp, Belgium. olivier.vanderveken@uza.be
Marijke Dieltjens
Kristien Wouters
Wilfried A De Backer
Paul H Van de Heyning
Marc J Braem

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOral appliance (OA) therapy is increasingly prescribed as a non-continuous positive airway pressure treatment modality for sleep-disordered breathing (SDB). Although OA therapy is reported to be efficacious for the treatment of SDB, data on compliance remain limited to self-report.

methodsIn this 3-month prospective clinical trial, the main outcome was to assess the safety and feasibility of an objective measurement of compliance during OA therapy using an embedded microsensor thermometer with on-chip integrated readout electronics in 51 consecutive patients with an established diagnosis of SDB (AHI 18.0 ± 11.9/h; age 47 ± 10 y; BMI 26.6 ± 4.0 kg/m(2); men/women: 31/20). Patients were unaware of the purpose of the study.

resultsNo microsensor-related adverse events were recorded. In addition, no problems were encountered during the readout of the compliance data. Out of 51 microsensors, one had a technical defect and was lost to follow-up. In this study, the overall objective mean rate of OA use was 6.6 ± 1.3 h per day with a regular OA users' rate of 82% at the 3-month follow-up. Statistical analysis revealed no significant differences between objective and self-reported OA compliance data in this study. Measurement of the objective OA compliance allowed us to calculate the mean disease alleviation (MDA) as the product of objective compliance and therapeutic efficacy. MDA serves as a measure of the overall therapeutic effectiveness, and turned out to be 51.1%.

conclusionsThe results illustrate the safety and feasibility of objective measurement of OA compliance. The objective measurement of OA compliance allows for calculation of the MDA.

Indexed as

Micro-Electrical-Mechanical SystemsOrthodontic AppliancesAdultContinuous Positive Airway PressureEquipment DesignEquipment SafetyFemaleHumansMaleMiddle AgedMonitoring, PhysiologicPatient CompliancePolysomnographyProspective StudiesSeverity of Illness IndexSleep Apnea Syndromes

Identifiers

PMID22993169
PMCPMC3534260

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.