Evidence map›Paper›PMID 28913630›Full record

Trial reportSleep & breathing = Schlaf & Atmung2018

Durability of treatment effects of the Sleep Position Trainer versus oral appliance therapy in positional OSA: 12-month follow-up of a randomized controlled trial.

Maurits H T de Ruiter, Linda B L Benoist, Nico de Vries, Jan de Lange

Erratum issued Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Sleep & breathing = Schlaf & Atmung, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02045576 (Positional Therapy With the Sleep Position Trainer Versus Oral Appliance Therapy in Patients With Position Dependent Obstructive Sleep Apnea; A Randomised Controlled Trial), which is not on this map. Cited by 25 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
25citing papers in PubMed, 5 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.

NCT02045576 nacompletednot on this map

Positional Therapy With the Sleep Position Trainer Versus Oral Appliance Therapy in Patients With Position Dependent Obstructive Sleep Apnea; A Randomised Controlled Trial

TypeinterventionalSponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Ran2013 to 2016Enrolled99ConditionsObstructive Sleep Apnea, Sleep Position Trainer, Oral Appliance TherapyArmssleep position trainer, Oral Appliance Therapy
3 · Its place in the literature

Who cites it

25 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Large variability in definitions of sleep apnea indices used in clinical studies.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2024
    Pooled it
  5. European Respiratory Society guideline on non-CPAP therapies for obstructive sleep apnoea.European respiratory review : an official journal of the European Respiratory Society · 2021
    Guideline
  6. Trial
  7. Trial
  8. Effect of position therapy and oral devices on sleep parameters in patients with obstructive sleep apnea.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2021
    Trial
  9. Trial
  10. Trial
  11. NightBalance Sleep Position Treatment Device Versus Auto-Adjusting Positive Airway Pressure for Treatment of Positional Obstructive Sleep Apnea.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2019
    Trial
  12. Review
  13. International Consensus Statement on Obstructive Sleep Apnea.International forum of allergy & rhinology · 2023
    Review
  14. Review
  15. Persistent OSA in obese children: does body position matter?Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2021
    Article
  16. Making Sense of the Noise: Toward Rational Treatment for Obstructive Sleep Apnea.American journal of respiratory and critical care medicine · 2020
    Article
  17. Efficacy and long-term follow-up of positional therapy by vibrotactile neck-based device in the management of positional OSA.Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine · 2020
    Article
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

4 authors.

Maurits H T de RuiterDepartment of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands.
Linda B L BenoistDepartment of Otorhinolaryngology Head and Neck Surgery, OLVG West, Jan Tooropstraat 164 1061 AE, Amsterdam, The Netherlands. l.benoist@erasmusmc.nl.ORCID 0000-0002-1713-6874
Nico de VriesDepartment of Otorhinolaryngology Head and Neck Surgery, OLVG West, Jan Tooropstraat 164 1061 AE, Amsterdam, The Netherlands.
Jan de LangeDepartment of Oral and Maxillofacial Surgery, Academic Medical Center, Amsterdam, The Netherlands.

Funding

Fonds NutsOhra Project 1104-031
6 · The paper itself

Abstract

purposeThe Sleep Position Trainer (SPT) is a new option for treating patients with positional obstructive sleep apnea (POSA). This study investigated long-term efficacy, adherence, and quality of life during use of the SPT device compared with oral appliance therapy (OAT) in patients with POSA.

methodsThis prospective, multicenter trial randomized patients with mild to moderate POSA (apnea-hypopnea index [AHI] 5-30/h) to SPT or OAT. Polysomnography was performed at baseline and after 3 and 12 months' follow-up. The primary endpoint was OSA severity; adherence, quality of life, and adverse events were also assessed.

resultsNinety-nine patients were randomized and 58 completed the study (29 in each group). Median AHI in the SPT group decreased from 13.2/h at baseline to 7.1/h after 12 months (P < 0.001); corresponding values in the OAT group were 13.4/h and 5.0/h (P < 0.001), with no significant between-group difference (P = 1.000). Improvements throughout the study were maintained at 12 months. Long-term median adherence was also similar in the two treatment groups; the proportion of patients who used their device for ≥ 4 h for 5 days in a week was 100% in the SPT group and 97.0% in the OAT group (P = 0.598).

conclusionsThe efficacy of SPT therapy was maintained over 12 months and was comparable to that of OAT in patients with mild to moderate POSA. Adherence was relatively high, and similar in the two groups.

trial registrationwww.clinicaltrials.gov (NCT02045576).

Indexed as

Mandibular AdvancementAdultFemaleFollow-Up StudiesHumansMaleMiddle AgedQuality of LifeSleep Apnea, ObstructiveTreatment OutcomeObstructive sleep apneaOral appliance therapyPositional therapyRandomized controlled trialSleep position

Identifiers

PMID28913630
PMCPMC5918490

What Socratic holds

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LicenceCC BY
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 Socratic graph.