PURPOSE: The aim of our randomized clinical trial is to produce stronger evidence supporting barbed repositioning pharyngoplasty (BRP) as a therapeutic option for the treatment of obstructive sleep apnea (OSA). METHODS: The trial was a single-center prospective controlled trial with two parallel arms (group A: BRP; group B: observation) and randomization. Baseline and 6-month polygraphy evaluating the apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS) were performed. To test the differences among groups of Student's t test, the role of each factor (univariate analysis) and their independent effect (multivariate analysis) was explored using logistic regression model as appropriate. Linear regression was also conducted. RESULTS: A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group. BRP showed to be more effective than observation. Logistic regression showed that preoperative AHI is related significantly to postoperative AHI within the BRP group. A linear regression showed that higher baseline AHI predicts more significant postoperative absolute AHI reduction. CONCLUSIONS:BRP appears to be a promising technique and might be included within the surgical armamentarium of a sleep surgeon. Patients affected by severe OSA may benefit from this surgery with more significant reduction of AHI values.
RCT Entities:
PURPOSE: The aim of our randomized clinical trial is to produce stronger evidence supporting barbed repositioning pharyngoplasty (BRP) as a therapeutic option for the treatment of obstructive sleep apnea (OSA). METHODS: The trial was a single-center prospective controlled trial with two parallel arms (group A: BRP; group B: observation) and randomization. Baseline and 6-month polygraphy evaluating the apnea hypopnea index (AHI), oxygen desaturation index (ODI), and lowest oxygen saturation (LOS) were performed. To test the differences among groups of Student's t test, the role of each factor (univariate analysis) and their independent effect (multivariate analysis) was explored using logistic regression model as appropriate. Linear regression was also conducted. RESULTS: A significant reduction of AHI, ODI, LOS, and Epworth Sleepiness Scale (ESS) values was recorded in the BRP group. BRP showed to be more effective than observation. Logistic regression showed that preoperative AHI is related significantly to postoperative AHI within the BRP group. A linear regression showed that higher baseline AHI predicts more significant postoperative absolute AHI reduction. CONCLUSIONS: BRP appears to be a promising technique and might be included within the surgical armamentarium of a sleep surgeon. Patients affected by severe OSA may benefit from this surgery with more significant reduction of AHI values.
Entities:
Keywords:
Barbed repositioning pharyngoplasty; OSA; OSAS; Outcome; Sleep surgery
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