Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Apnea Hypopnea Index (AHI/h)
研究概览
简要总结
This study looks at how jaw surgery called maxillomandibular advancement with counterclockwise rotation affects breathing during sleep in people with moderate to severe obstructive sleep apnea who cannot tolerate standard treatments such as Continous Positive Airway pressure treatment. The participants are followed over time to see whether the surgery improves sleep apnea symptoms, daytime sleepiness, and airway size, and whether these improvements last. Advanced three-dimensional imaging and airflow analysis are used to better understand how the surgery changes the airway and breathing. The goal is to evaluate the long-term effectiveness and safety of this surgical treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.
- •Residence and/or registration in Dalarna County
- •Body mass index (BMI; kg/m^2) between 15 and 35
- •Documented failure of CPAP or mandibular advancement therapy.
排除标准
- •Medical conditions contraindicating general anesthesia.
- •American Society of Anesthesiologists Physical Status (ASA) Class III-VI
- •Central sleep apnea
- •Narcolepsy
- •Prior orthognathic surgery
- •History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include;
- •Hypothyroidism
- •Acromegaly
- •Diabetes mellitus
- •Active generalized rheumatoid arthritis
- •Clinically manifest periodic limb movement disorder
- •Restless legs syndrome.
研究组 & 干预措施
Intervention
Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery
干预措施: Maxillomandibular advancement surgery with counterclockwise rotation (Procedure)
结局指标
主要结局
Apnea Hypopnea Index (AHI/h)
时间窗: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Change in AHI/h. Lower value means better outcome, value \< 5 is considered healthy.
次要结局
- Upper airway volume(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
- Airway velocity(Registration presurgically and at 3 months, 2 years and at 5 years post operatively.)
- Epworth Sleepiness Scale (ESS)(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
- Blood pressure(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
- Quality of Life (QoL), Short Form-36 Health Survey(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
- Quality of Life (QoL), Oral Health Impact Profile - Swedish version(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
- Quality of Life (QoL), Jaw Function Limitation Scale.(Registration presurgically and at 3 months, 2 years and 5 years post operatively)
研究者
Jani Talvilahti
Head of Maxillofacial Surgery, DDS
Dalarna County Council, Sweden