Computational protocol: Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial

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Protocol publication

[…] Statistical analyses were performed using SPSS software (version 17.0; SPSS, Inc., Chicago, IL, USA) and G*Power (version 3.1.5; University Kiel, Germany). For the relative small sample size of the present study, we analyzed all variables using non-parametric approaches. The sample size for this study was estimated using the primary outcome effects (VAS) in two previously published studies , . Using a two-tailed Wilcoxon signed-rank test for calculating the sample size (normal parent distribution; effect size, 1.0; type I error, 0.05; power, 80%), we got a sample size of 11. For considering a 20% drop-out rate to fulfill the criteria of intention-to-treat analysis, we needed at least 14 participants to attend this study. Accordingly, we decided to enroll 30 patients with 15 in each group for showing the difference in mean before and after VAS scores. Two interim analyses were performed at the end of the first year during the trial: 1) the levels of significance maintained an overall P value of 0.05 and were calculated according to the O'Brien-Fleming stopping boundaries, and 2) this final analysis used a Z score of 1.985 with an associated P value of 0.0471 . We planned to stop early if exceptional benefit or harm had been shown.Further implementing the Kolmogorov-Smirnov test, distributions of patient clinical characteristics, subjective and objective snoring parameters were non-Gaussian and the descriptive statistics of these variables were presented as means (standard errors). Percentage (%) of change ([after value-before value]/[before value] × 100) in subjective snoring as well as in objective acoustic factors and differences between groups were analyzed with the Wilcoxon signed ranks test or the Mann-Whitney U test, as appropriate. Categorical variables were analyzed with the Fisher's exact test or the chi-square test. A P value of less than 0.05 was considered to be statistically significant. […]

Pipeline specifications

Software tools SPSS, G*Power
Application Miscellaneous
Organisms Homo sapiens
Diseases Cleft Palate, Sleep Apnea Syndromes