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Randomized Controlled Trial
. 2020 Sep 22;324(12):1168-1179.
doi: 10.1001/jama.2020.14265.

Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial

Stuart MacKay  1   2   3 , A Simon Carney  4   5 , Peter G Catcheside  6 , Ching Li Chai-Coetzer  6   7 , Michael Chia  8 , Peter A Cistulli  9   10 , John-Charles Hodge  11 , Andrew Jones  1   2   12 , Billingsley Kaambwa  13 , Richard Lewis  14   15 , Eng H Ooi  5   16 , Alison J Pinczel  6 , Nigel McArdle  17   18 , Guy Rees  19 , Bhajan Singh  17   18   20 , Nicholas Stow  21 , Edward M Weaver  22   23 , Richard J Woodman  24 , Charmaine M Woods  5   16 , Aeneas Yeo  8 , R Doug McEvoy  6   7
Affiliations
Randomized Controlled Trial

Effect of Multilevel Upper Airway Surgery vs Medical Management on the Apnea-Hypopnea Index and Patient-Reported Daytime Sleepiness Among Patients With Moderate or Severe Obstructive Sleep Apnea: The SAMS Randomized Clinical Trial

Stuart MacKay et al. JAMA. .

Abstract

Importance: Many adults with obstructive sleep apnea (OSA) use device treatments inadequately and remain untreated.

Objective: To determine whether combined palatal and tongue surgery to enlarge or stabilize the upper airway is an effective treatment for patients with OSA when conventional device treatment failed.

Design, setting, and participants: Multicenter, parallel-group, open-label randomized clinical trial of upper airway surgery vs ongoing medical management. Adults with symptomatic moderate or severe OSA in whom conventional treatments had failed were enrolled between November 2014 and October 2017, with follow-up until August 2018.

Interventions: Multilevel surgery (modified uvulopalatopharyngoplasty and minimally invasive tongue volume reduction; n = 51) or ongoing medical management (eg, advice on sleep positioning, weight loss; n = 51).

Main outcomes and measures: Primary outcome measures were the apnea-hypopnea index (AHI; ie, the number of apnea and hypopnea events/h; 15-30 indicates moderate and >30 indicates severe OSA) and the Epworth Sleepiness Scale (ESS; range, 0-24; >10 indicates pathological sleepiness). Baseline-adjusted differences between groups at 6 months were assessed. Minimal clinically important differences are 15 events per hour for AHI and 2 units for ESS.

Results: Among 102 participants who were randomized (mean [SD] age, 44.6 [12.8] years; 18 [18%] women), 91 (89%) completed the trial. The mean AHI was 47.9 at baseline and 20.8 at 6 months for the surgery group and 45.3 at baseline and 34.5 at 6 months for the medical management group (mean baseline-adjusted between-group difference at 6 mo, -17.6 events/h [95% CI, -26.8 to -8.4]; P < .001). The mean ESS was 12.4 at baseline and 5.3 at 6 months in the surgery group and 11.1 at baseline and 10.5 at 6 months in the medical management group (mean baseline-adjusted between-group difference at 6 mo, -6.7 [95% CI, -8.2 to -5.2]; P < .001). Two participants (4%) in the surgery group had serious adverse events (1 had a myocardial infarction on postoperative day 5 and 1 was hospitalized for observation following hematemesis of old blood).

Conclusions and relevance: In this preliminary study of adults with moderate or severe OSA in whom conventional therapy had failed, combined palatal and tongue surgery, compared with medical management, reduced the number of apnea and hypopnea events and patient-reported sleepiness at 6 months. Further research is needed to confirm these findings in additional populations and to understand clinical utility, long-term efficacy, and safety of multilevel upper airway surgery for treatment of patients with OSA.

Trial registration: Australian New Zealand Clinical Trials Registry: ACTRN12614000338662.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr MacKay reported receiving grants from National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation 2013 Prabha Seshadri Research Grant during the conduct of the study and nonfinancial support from Genio-Nyxoah and grants from Garnett-Passe Rodney Williams Foundation and Illawarra Health and Medical Research Institute outside the submitted work. Dr Carney reported receiving grants from National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study. Dr Catcheside reported receiving grants from National Health and Medical Research Council of Australia and from Flinders University during the conduct of the study; receiving grants from the Cooperative Research Centre for Alertness, Safety and Productivity, the National Health and Medical Research Council of Australia, and the Flinders Foundation Health Seed Grant and nonfinancial support from Philips Respironics, Air Liquide Healthcare, and Gorman Promed outside the submitted work; having a patent to Sleep Disorder Diagnosis, App No. AU 2018904007, US 62/812066 pending and a patent to decision support software for sleep disorder identification, February 28, 2019, US 61/815562 Sleep Disorder Data Fidelity Management System, March 8, 2019, pending. Dr Chai-Coetzer reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study. Dr Cistulli reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study and nonfinancial support from ResMed Inc; nonfinancial support from Zephyr Sleep Technologies; personal fees from SomnoMed, Signifier Medical, Wolter Kluwers, and Quintessence Publishing; and a provision of clinical trial services from Bayer outside the submitted work. Dr Jones reported receiving grants from Illawarra Sleep Medicine Centre during the conduct of the study. Dr Kaambwa reported receiving grants from the Australian National Health and Medical Research Council during the conduct of the study. Dr Lewis reported receiving consulting fees for Nyxoah SA (Belgium) as an investigator in 3 trials of a new hypoglossal nerve stimulator for obstructive sleep apnea. Dr Ooi reported receiving grants from the National Health and Medical Research Council and Flinders University during the conduct of the study and personal fees from Medtronic outside the submitted work. Dr Pinczel reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study. Dr McArdle reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study and grants from Oventus (Brisbane, Australia), Nyxoah (Mont-Saint Guibert, Belgium), and Zelda Therapeutics (Australia) outside the submitted work. Dr Weaver reported being a research consultant for Nyxoah SA outside the submitted work and practicing sleep surgery. Dr Yeo reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, Flinders University, and The Repat Foundation Prabha Seshadri Research Grant during the conduct of the study. Dr McEvoy reported receiving grants from the National Health and Medical Research Council of Australia, Flinders University, and The Repat Foundation during the conduct of the study and grants from Philips Respironics and ResMed outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Recruitment, Randomization, and Flow of Participants in a Study of the Effect of Upper Airway Surgery vs Ongoing Medical Management on Patients With Obstructive Sleep Apnea
Figure 2.
Figure 2.. Apnea-Hypopnea Index (AHI) and Epworth Sleepiness Scale (ESS) Outcomes in a Study of the Effect of Upper Airway Surgery vs Ongoing Medical Management on Patients With Obstructive Sleep Apnea (OSA)
The ends of the boxes in the boxplots are located at the first and third quartiles, with the black line in the middle illustrating the median. The dashed line signifies the mean. Whiskers extend to the upper and lower adjacent values, the location of the furthest point within a distance of 1.5 interquartile ranges from the first and third quartiles. The parallel line plot contains 1 vertical line for each patient which extends from their baseline value to their 6-month value. Descending lines indicate an improvement in symptoms. Baseline values are placed in ascending order for the surgery group and descending order for the ongoing medical management group. A, The AHI indicates the number of apnea and hypopnea events per hour of sleep (0-5 is classified as normal; 5-14, mild OSA; 15-30, moderate OSA; >30, severe OSA; a change of at least 15 is considered clinically meaningful and can move a patient 2 levels from severe to mild with established benefit for health). B, The ESS evaluates sleepiness (range, 0-24; higher scores indicate greater severity; score >10 signifies pathological sleepiness; a change of 2 is the minimally important clinical difference).
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