Evidence map›Paper›PMID 30945740›Full record

ArticleSleep2019

Sleep Apnea Multilevel Surgery (SAMS) trial protocol: a multicenter randomized clinical trial of upper airway surgery for patients with obstructive sleep apnea who have failed continuous positive airway pressure.

A Simon Carney, Nick A Antic, Peter G Catcheside, Ching Li Chai-Coetzer, Peter A Cistulli, Billingsley Kaambwa, Stuart G MacKay, Alison J Pinczel, Edward M Weaver, Richard J Woodman and 2 more

Open access · bronzeAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Sleep, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
1.2field-weighted citation impact, top 22% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed, 17 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Sleep surgery randomized clinical trials: design and execution are important.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 · 2023
    Article
  7. Article
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

12 authors at 3 institutions in 2 countries.

A Simon CarneyDepartment of Surgery, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Nick A AnticAdelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Peter G CatchesideAdelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Ching Li Chai-CoetzerAdelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Peter A CistulliDepartment of Respiratory Medicine and Sleep, Royal North Shore Hospital, St Leonards, NSW, Australia.
Billingsley KaambwaHealth Economics Unit, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Stuart G MacKayIllawarra ENT Head and Neck Clinic, Wollongong, NSW, Australia.
Alison J PinczelAdelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Edward M WeaverDepartment of Otolaryngology/Head and Neck Surgery, University of Washington, Staff Surgeon, Seattle Veterans Affairs Medical Center, Seattle, WA.
Richard J WoodmanFlinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Charmaine M WoodsDepartment of Otolaryngology Head and Neck Surgery, Southern Adelaide Local Health Network, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
R Doug McEvoyAdelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
Flinders University · AUThe University of Sydney · AUUniversity of Washington Medical Center · US

Funding

Nasal Turbinate Reduction & CPAP Outcomes for Sleep Apnea: A Sham-Controlled RCTR01HL084139 · NHLBI · UNIVERSITY OF WASHINGTON · PI WEAVER, EDWARD M · 2007 to 2011
$3.0M
NHLBI NIH HHS R01 HL084139
6 · The paper itself

Abstract

STUDY

objectivesObstructive sleep apnea (OSA) is a serious and costly public health problem. The main medical treatment, continuous positive airway pressure, is efficacious when used, but poorly tolerated in up to 50% of patients. Upper airway reconstructive surgery is available when medical treatments fail but randomized trial evidence supporting its use is limited. This protocol details a randomized controlled trial designed to assess the clinical effectiveness, safety, and cost-effectiveness of a multilevel upper airway surgical procedure for OSA.

methodsA prospective, parallel-group, open label, randomized, controlled, multicenter clinical trial in adults with moderate or severe OSA who have failed or refused medical therapies. Six clinical sites in Australia randomly allocated participants in a 1:1 ratio to receive either an upper airway surgical procedure consisting of a modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction, or to continue with ongoing medical management, and followed them for 6 months.

resultsPrimary outcomes: difference between groups in baseline-adjusted 6 month OSA severity (apnea-hypopnea index) and subjective sleepiness (Epworth Sleepiness Scale). Secondary outcomes: other OSA symptoms (e.g. snoring and objective sleepiness), other polysomnography parameters (e.g. arousal index and 4% oxygen desaturation index), quality of life, 24 hr ambulatory blood pressure, adverse events, and adherence to ongoing medical therapies (medical group).

conclusionsThe Sleep Apnea Multilevel Surgery (SAMS) trial is of global public health importance for testing the effectiveness and safety of a multilevel surgical procedure for patients with OSA who have failed medical treatment. CLINICAL

trial registrationMultilevel airway surgery in patients with moderate-severe Obstructive Sleep Apnea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness. https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366019&isReview=true Australian New Zealand Clinical Trials Registry ACTRN12614000338662, prospectively registered on 31 March 2014.

Indexed as

AdultAustraliaBlood Pressure Monitoring, AmbulatoryContinuous Positive Airway PressureFemaleHumansMaleMiddle AgedMulticenter Studies as TopicPolysomnographyProspective StudiesPulmonary Surgical ProceduresQuality of LifeRandomized Controlled Trials as TopicSleep Apnea, ObstructiveSnoringobstructive sleep apneasurgerytongue reductionUPPP

Identifiers

PMID30945740
PMCPMC7368346
OpenAlexW2926952956

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.