Ji H Choi1, Jae H Cho, Yoo-Sam Chung, Jeong-Whun Kim, Sung W Kim. 1. Department of Otorhinolaryngology-Head and Neck Surgery, Korea University Ansan Hospital, College of Medicine, Korea University, Ansan, Republic of Korea.
Abstract
OBJECTIVES/HYPOTHESIS: The effect of the Pillar implant on mild sleep-disordered breathing (SDB) has been assessed in various studies. However, most of these were conducted among a non-Asian population at a single institution. Therefore, the aim of this study was to prospectively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea (OSA) at multiple centers. STUDY DESIGN: Multicenter prospective clinical trials. METHODS: This study included consecutive subjects with simple snoring or mild OSA. We examined subjective symptoms (snoring intensity, frequency, witnessed apnea, and daytime sleepiness) and objective snoring and respiratory parameters (snoring duration [proportion of sleep while snoring louder than 50 dB], snoring loudness, apnea-hypopnea index, respiratory disturbance index, minimum arterial oxygen saturation, and oxygen desaturation index ≥ 4%) at 3 to 6 months after surgery. Adverse events were also investigated. RESULTS:Twenty-nine subjects with mild SDB completed the study. Whole group analysis found significant improvements in various subjective symptoms, but not in the objective snoring and respiratory parameters. A subgroup analysis of subjects with mild OSA (n = 11) found significant alleviation in various subjective symptoms, apnea-hypopnea index, respiratory disturbance index, and oxygen desaturation index ≥ 4%. No major complication related to surgery was observed, and most minor adverse effects were resolved without morbidity. CONCLUSIONS: In selected Korean patients, the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA. LEVEL OF EVIDENCE: 2b.
RCT Entities:
OBJECTIVES/HYPOTHESIS: The effect of the Pillar implant on mild sleep-disordered breathing (SDB) has been assessed in various studies. However, most of these were conducted among a non-Asian population at a single institution. Therefore, the aim of this study was to prospectively evaluate the efficacy of the Pillar implant in Asian patients with simple snoring and mild obstructive sleep apnea (OSA) at multiple centers. STUDY DESIGN: Multicenter prospective clinical trials. METHODS: This study included consecutive subjects with simple snoring or mild OSA. We examined subjective symptoms (snoring intensity, frequency, witnessed apnea, and daytime sleepiness) and objective snoring and respiratory parameters (snoring duration [proportion of sleep while snoring louder than 50 dB], snoring loudness, apnea-hypopnea index, respiratory disturbance index, minimum arterial oxygen saturation, and oxygen desaturation index ≥ 4%) at 3 to 6 months after surgery. Adverse events were also investigated. RESULTS: Twenty-nine subjects with mild SDB completed the study. Whole group analysis found significant improvements in various subjective symptoms, but not in the objective snoring and respiratory parameters. A subgroup analysis of subjects with mild OSA (n = 11) found significant alleviation in various subjective symptoms, apnea-hypopnea index, respiratory disturbance index, and oxygen desaturation index ≥ 4%. No major complication related to surgery was observed, and most minor adverse effects were resolved without morbidity. CONCLUSIONS: In selected Korean patients, the Pillar implant significantly improved not only subjective symptoms of mild SDB but also respiratory disturbances in mild OSA. LEVEL OF EVIDENCE: 2b.
Authors: Hind A Beydoun; May A Beydoun; Hong Cheng; Anjum Khan; Shaker M Eid; Carolina Alvarez-Garriga; Colin Anderson-Smits; Alan B Zonderman; Danica Marinac-Dabic Journal: J Craniomaxillofac Surg Date: 2018-05-24 Impact factor: 2.078
Authors: Eric A Mann; Srinivas Nandkumar; Nancy Addy; B Gail Demko; Neil S Freedman; M Boyd Gillespie; William Headapohl; Douglas B Kirsch; Barbara A Phillips; Ilene M Rosen; Logan D Schneider; Carl J Stepnowsky; Kathleen L Yaremchuk; Malvina B Eydelman Journal: J Clin Sleep Med Date: 2020-01-14 Impact factor: 4.062