The Annals of otology, rhinology, and laryngology · 2008
Adjustable tongue advancement for obstructive sleep apnea: a pilot study.
Клиническое исследование I фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Hamans Evert, Boudewyns An, Stuck Boris A, Baisch Alexander, Willemen Marc, Verbraecken Johan, Van de Heyning Paul
Аннотация
OBJECTIVES: Surgical treatment of obstructive sleep apnea (OSA) caused by hypopharyngeal collapse of the upper airway can be considered in patients who are intolerant to continuous positive airway pressure (CPAP). The present procedures addressing the hypopharynx are invasive and have substantial morbidity and limited efficacy.
METHODS: Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway.
RESULTS: The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred.
CONCLUSIONS: Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.
METHODS: Ten patients (mean age, 44 years) with moderate to severe OSA, ie, an apnea-hypopnea index (AHI) between 15 and 50, with CPAP intolerance were included in a prospective, nonrandomized, multicenter study to evaluate the feasibility, safety, and efficacy of a novel tongue advancement procedure. The procedure consists of the implantation of a tissue anchor in the tongue base and an adjustment spool at the mandible. Titration of this tissue anchor results in advancement of the tongue and a patent upper airway.
RESULTS: The mean AHI decreased from 22.8 at baseline to 11.8 at the 6-month follow-up (p = 0.007). The Epworth Sleepiness Scale score decreased from 11.4 at baseline to 7.7 at the 6-month follow-up (p = 0.094), and the snoring score decreased from 7.5 at baseline to 3.9 at the 6-month follow-up (p = 0.005). Four technical adverse events were noted, and 1 clinical adverse event occurred.
CONCLUSIONS: Adjustable tongue advancement is a feasible and relatively safe way to reduce the AHI and snoring in selected patients with moderate to severe OSA and CPAP intolerance. Technical improvements and refinements to the procedure are ongoing.