Evidence map›Paper›PMID 34608859›Full record

Trial reportJournal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine2022

Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study.

Hélène Van Gaver, Sara Op de Beeck, Marijke Dieltjens, Jan De Backer, Johan Verbraecken, Wilfried A De Backer, Paul H Van de Heyning, Marc J Braem, Olivier M Vanderveken

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase IV
In one paragraph

Trial report in Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01532050 (PROMAD), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 16% of its field
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.

NCT01532050 phase4completednot on this map

PROMAD : Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea

TypeinterventionalSponsorethisch.comite@uza.beRan2012 to 2015Enrolled100ConditionsObstructive Sleep Apnea SyndromeArmsMandibular Advancement Device ( MAD)
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 21 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Review
  10. Article
  11. The role of oral appliance therapy in obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2023
    Review
  12. Article
  13. Article
  14. Non-CPAP therapy for obstructive sleep apnoea.Breathe (Sheffield, England) · 2022
    Review
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

9 authors at 3 institutions in 1 country.

Hélène Van GaverFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Sara Op de BeeckFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Marijke DieltjensFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Jan De BackerFluidda Nevada, Kontich, Belgium.
Johan VerbraeckenFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Wilfried A De BackerFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Paul H Van de HeyningFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Marc J BraemFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Olivier M VandervekenFaculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Antwerp University Hospital · BEUniversity of Antwerp · BEFluidda (Belgium) · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

STUDY

objectivesMandibular advancement devices (MADs) are a noninvasive treatment option for patients with obstructive sleep apnea (OSA) and act by increasing the upper airway volume. However, the exact therapeutic mechanism of action remains unclear. The aim of this study was to assess MAD mechanisms using functional imaging that combines imaging techniques and computational fluid dynamics and assess associations with treatment outcome.

methodsOne hundred patients with OSA were prospectively included and treated with a custom-made MAD at a fixed 75% protrusion. A low-dose computed tomography scan was made with and without MADs for computational fluid dynamics analysis. Patients underwent a baseline and 3-month follow-up polysomnography to evaluate treatment efficacy. A reduction in apnea-hypopnea index ≥ 50% defined treatment response.

resultsOverall, 71 patients completed both 3-month follow-up polysomnography and low-dose computed tomography scan with computational fluid dynamics analysis. MAD treatment significantly reduced the apnea-hypopnea index (16.5 [10.4-23.6] events/h to 9.1 [3.9-16.4] events/h;

conclusionsMAD acts by increasing the total upper airway volume, predominantly due to an increase in the velopharyngeal volume. Responders showed a significant increase in the total upper airway volume with MAD treatment, while there was no significant increase in nonresponders. Findings add evidence to implement functional imaging using computational fluid dynamics in routine MAD outcome prediction. CLINICAL

trial registrationRegistry: ClinicalTrials.gov; Name: Predicting Therapeutic Outcome of Mandibular Advancement Device Treatment in Obstructive Sleep Apnea; URL: https://clinicaltrials.gov/ct2/show/NCT01532050; Identifier: NCT01532050. CITATION: Van Gaver H, Op de Beeck S, Dieltjens M, et al. Functional imaging improves patient selection for mandibular advancement device treatment outcome in sleep-disordered breathing: a prospective study.

Indexed as

Mandibular AdvancementSleep Apnea, ObstructiveHumansOcclusal SplintsPatient SelectionProspective StudiesTreatment OutcomeCFDMADobstructive sleep apneaoral appliancesOSA

Identifiers

PMID34608859
PMCPMC8883076
OpenAlexW3201681385

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.