SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients

Pang KP 1 , Baptista PM 2 , Olszewska E 3 , Braverman I 4 , Carrasco-Llatas M 5 , Kishore S 6 Show all authors , Chandra S 7 , Yang HC 8 , Chan YH 9 , Pang KA 10 , Pang EB 11 , Rotenberg B 12

Affiliations 

  • 1 Asia Sleep Centre, Department of Otolaryngology, Paragon, Singapore,. [email protected]
  • 2 Clinica Universidad de Navarra, Department of Otolaryngology, Pamplona, Navarra, Spain
  • 3 Medical University of Bialystok, ENT Department, Poland
  • 4 Hillel Yaffe Medical Center, Technion Faculty Medicine, Department of Otolaryngology Head and Neck Surgery, Haifa, Israel
  • 5 Hospital Universitario Dr. Peset. ENT Department, Valencia. Spain
  • 6 Nova Specialty Hospital, Otolaryngology Department, Hyderabad, India
  • 7 Belle Vue Clinic & Hospital, ENT Department, Kolkata, India
  • 8 Chonnam National University Hospital, Otolaryngology Department, Korea
  • 9 National University Singapore, School of Medicine, Biostatistics Unit, Singapore
  • 10 Asia Sleep Centre, Department of Otolaryngology, Paragon, Singapore
  • 11 University of Glasgow, Medicine Faculty, Scotland
  • 12 Western University, Otolaryngology Department, London, Ontario, Canada
Med J Malaysia, 2020 03;75(2):117-123.
PMID: 32281591

Abstract

OBJECTIVE: To demonstrate SLEEP-GOAL as a more holistic and comprehensive success criterion for Obstructive Sleep Apnoea (OSA) treatment.

METHODS: A prospective 7-country clinical trial of 302 OSA patients, who met the selection criteria, and underwent nose, palate and/or tongue surgery. Pre- and post-operative data were recorded and analysed based on both the Sher criteria (apnoea hypopnea index, AHI reduction 50% and <20) and the SLEEP-GOAL.

RESULTS: There were 229 males and 73 females, mean age of 42.4±17.3 years, mean BMI 27.9±4.2. The mean VAS score improved from 7.7±1.4 to 2.5±1.7 (p<0.05), mean Epworth score (ESS) improved from 12.2±4.6 to 4.9±2.8 (p<0.05), mean body mass index (BMI) decreased from 27.9±4.2 to 26.1±3.7 (p>0.05), gross weight decreased from 81.9±14.3kg to 76.6±13.3kg. The mean AHI decreased 33.4±18.9 to 14.6±11.0 (p<0.05), mean lowest oxygen saturation (LSAT) improved 79.4±9.2% to 86.9±5.9% (p<0.05), and mean duration of oxygen <90% decreased from 32.6±8.9 minutes to 7.3±2.1 minutes (p<0.05). The overall success rate (302 patients) based on the Sher criteria was 66.2%. Crosstabulation of respective major/minor criteria fulfilment, based on fulfilment of two major and two minor or better, the success rate (based on SLEEP-GOAL) was 69.8%. Based solely on the Sher criteria, 63 patients who had significant blood pressure reduction, 29 patients who had BMI reduction and 66 patients who had clinically significant decrease in duration of oxygen <90% would have been misclassified as "failures".

CONCLUSION: AHI as a single parameter is unreliable. Assessing true success outcomes of OSA treatment, requires comprehensive and holistic parameters, reflecting true end-organ injury/function; the SLEEP-GOAL meets these requirements.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

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