1.SLEEP-GOAL: A multicenter success criteria outcome study on 302 obstructive sleep apnoea (OSA) patients
Kenny P. Pang ; Peter M Baptista J ; Ewa Olszewska ; Itzhak Braverman ; Marina Carrasco Llatas ; Srivinas Kishore ; Sudipta Chandra ; Hyung Chae Yang ; Yiong Huak Chan ; Kathleen Ann Pang ; Edward Benjamin Pang ; Brian Rotenberg
The Medical Journal of Malaysia 2020;75(2):117-123
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