Natural History of Central and Mixed Sleep Apneas Followed by Maxillomandibular Advancement for Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apnea-hypopnea index (AHI)
研究概览
简要总结
The goal of this observational prospective cohort study is to learn about the natural course of central and mixed sleep apneas that develop after maxillomandibular advancement (MMA) surgery for obstructive sleep apnea (OSA) in adult patients.
The main question it aims to answer is:
Do central and mixed apneas resolve, partially resolve, or persist in the long term after MMA?
Participants will:
Undergo a first postoperative polysomnography (PSG) at 3-6 months after MMA (part of standard care).
Be invited into the study if central/mixed apneas are detected (CMAI% >25%). Undergo a second PSG at least 12 months after MMA (extra study procedure)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years or older;
- •Mild to severe OSA as determined by a polysomnography (PSG) preoperatively;
- •Completion of MMA for OSA treatment;
- •Subjects with preoperative and postoperative PSG;
- •Patients who are present with MMA treatment-related central apneas postoperatively
排除标准
- •Patients who underwent other adjunctive procedures at the time of MMA (e.g., multi-piece Le Fort osteotomy, TMJ reconstruction);
- •Previous history of orthognathic surgery;
- •Cleft palate and syndromic patients.
研究组 & 干预措施
Adults with OSA who developed central and/or mixed sleep apneas after MMA
结局指标
主要结局
Apnea-hypopnea index (AHI)
时间窗: 12 months after MMA surgery
Central apnea index (CAI)
时间窗: 12 months after MMA surgery
Mixed apnea index (MAI)
时间窗: 12 months after MMA surgery
The percentage of central and mixed apneas of AHI (CMAI%)
时间窗: 12 months after MMA
次要结局
- Oxygen desaturation index (ODI)(12 months after MMA surgery)
- Lowest oxyhemoglobin saturation (LSAT)(12 months after MMA surgery)
研究者
Prof. dr. J. de Lange, MD DMD
Prof. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)