Quality of Life in Obstructive Sleep Apnea patiënts Treated With Maxillomandibular Advancement Surgery.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- SF-36
研究概览
简要总结
The aim of this observational study is to evaluate the impact of maxillomandibular advancement surgery on the quality of life in patients treated with obstructive sleep apnea.
The main question it aims to answer is:
Does MMA surgery in OSA patiënts improve their quality of life?
Patients will answer online surverys about their QoL and there will be data collected like length, weight and blood pressure.
详细描述
The aim of this study is to evaluate the impact of MMA surgery on the quality of life of patients with obstructive sleep apnea.
It was hypnotized that MMA does not result in a significant improvement in the quality of life in patients with OSA.
The main objective is the SF-36 questionnaire The secondary objectives are the; OHIP-14, ESS, FOSQ, EQ-5D-3L and OQLQ
Design: observational study
Study population: 80 Patients who qualify for MMA above the age of 18
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
- 是
入选标准
- •18 years and older.
- •Ability to speak, read and write Dutch.
- •Ability to follow up.
- •Ability to use a computer with internet connection and windows-software for uploading data
- •and online questionnaires.
- •Diagnosis with OSA. (only for the intervention group)
- •Expected to maintain current lifestyle (sports, medicine, diet etc.).
- •Qualifies for MMA surgery
- •Patients who provide informed consent
排除标准
- •Patients who do not qualify for MMA surgery
- •Medication used/ related to sleeping disorders.
- •Night or shifting work.
- •Severe chronic heart failure.
- •Medical history of known causes of tiredness by day or severe sleep disruption (insomnia,
- •PLMS, Narcolepsy).
- •Seizure disorder.
- •Known medical history of mental retardation, memory disorders or psychiatric disorders.
- •Patients with old type of pacemakers (It is possible that old types of peacemakers are not
- •Compatible with the electromagnetic radiation of the electronics of the SPT).
- •Shoulder, neck and back complaints.
- •Reversible morphological upper airway abnormalities (e.g. enlarged tonsils).
- •Inability to provide informed consent.
- •Simultaneous use of other treatment modalities to treat OSA.
- •Previous treatment for OSA with MRA or SPT
- •Pregnancy.
- •patients under the age of 18
- •Patients with mild or no OSA at all
结局指标
主要结局
SF-36
时间窗: 5 minutes
Survey
次要结局
- ESS(5 minutes)
- FOSQ(5 minutes)
- EQ-5D-3L(5 minutes)
- OHIP-14(5 minutes)
- OQLQ(5 minutes)