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; Charmaine M Woods; R Doug McEvoy

doi:10.1093/sleep/zsz056

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

Sleep. 2019 Jun 11;42(6):zsz056. doi: 10.1093/sleep/zsz056.

Authors

Affiliations

¹ Department of Surgery, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
² Adelaide Institute for Sleep Health, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
³ Respiratory and Sleep Services, Southern Adelaide Local Health Network, Flinders Medical Centre, Bedford Park, SA, Australia.
⁴ Department of Respiratory Medicine and Sleep, Royal North Shore Hospital, St Leonards, NSW, Australia.
⁵ Charles Perkins Centre, Faculty of Medicine and Health, University of Sydney, Sydney NSW, Australia.
⁶ Health Economics Unit, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
⁷ Illawarra ENT Head and Neck Clinic, Wollongong, NSW, Australia.
⁸ Department of Otolaryngology/Head and Neck Surgery, University of Washington, Staff Surgeon, Seattle Veterans Affairs Medical Center, Seattle, WA.
⁹ Flinders Centre for Epidemiology and Biostatistics, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.
¹⁰ Department of Otolaryngology Head and Neck Surgery, Southern Adelaide Local Health Network, College of Medicine and Public Health, Flinders University, Bedford Park, SA, Australia.

Abstract

Study objectives: Obstructive 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.

Methods: A 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.

Results: Primary 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).

Conclusions: The 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 registration: Multilevel 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.

Keywords: UPPP; obstructive sleep apnea; surgery; tongue reduction.

Publication types

Multicenter Study
Randomized Controlled Trial
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

MeSH terms

Adult
Australia
Blood Pressure Monitoring, Ambulatory
Continuous Positive Airway Pressure / methods*
Female
Humans
Male
Middle Aged
Polysomnography
Prospective Studies
Pulmonary Surgical Procedures / methods*
Quality of Life / psychology
Sleep Apnea, Obstructive / physiopathology*
Sleep Apnea, Obstructive / surgery*
Snoring / complications
Treatment Outcome

Associated data

ANZCTR/ACTRN12614000338662

Grants and funding

R01 HL084139/HL/NHLBI NIH HHS/United States