Multi-level airway surgery in patients with moderate-severe Obstructive Sleep Apnoea (OSA) who have failed medical management to assess change in OSA events and daytime sleepiness.

Prof. R. Doug McEvoy0 个研究点目标入组 102 人开始时间: 2014年3月31日最近更新: 2023年9月4日

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•Diagnosis of OSA (defined as Apnoea Hypopnoea Index, AHI, > 15 scored by AASM 2007 alternate criteria).
•- At least mild daytime sleepiness defined as ESS (Epworth Sleepiness Scale) > 8. We used this cut point to target those with at least mild daytime sleepiness, but consider that the requirement for the ESS to be > 8 will not adversely affect recruitment.
•- Failed CPAP treatment despite persistent, supervised attempts to implement CPAP, or been treated in a tertiary centre sleep lab or by an Australasian Sleep Association accredited sleep service and have not taken up CPAP when prescribed, and failed MAS therapy due to patient refusal, patient found to be unsuitable on dental grounds, patient intolerance, or were never offered MAS as a treatment option.
•- CPAP treatment reduces AHI to below 15 events per hour of sleep (N/A for outright refusers of CPAP).
•- Aged between 18 and 70 years.
•- Body mass index (BMI) less than or equal to 38kg/m2. a)For patients with BMI 35-38: patient will be deemed appropriate provided they are of strong surgical/anatomical suitability, which consists of size 3-4 tonsil, with Friedman tongue 1-2, and dynamic assessment confirming predominant palatine tonsillar collapse

•- Prior surgery on palate, tongue, mandible or maxilla. (Previous tonsillectomy is allowed.)
•- Nasal obstruction uncontrolled by medication or surgery.
•- Clinically significant retrognathia, confirmed by lateral skull x-ray (SNB angle < 72 degrees).
•- Moderate to severe COPD (FEV/FVC ratio < 70% and FEV 1 <50%).
•- Heart failure (New York Heart classes 2-4).
•- Recent history (last 3 months) of a major cardiovascular event i.e. MI, unstable angina, CVA; or major disorder of the pulmonary, renal or nervous systems.
•- Chronic narcotic use.
•- Major depression i.e. hospitalisation for depression, suicide attempt or symptoms necessitating antidepressant drug dose escalation in the previous 3 months.
•- Pregnant or breast feeding.
•- Unacceptable anaesthetic or surgical risk (e.g. anticoagulant or antiplatelet medication which cannot be withdrawn).
•- History of dysphagia or aspiration.
•- Commercial driver.

发起方

Prof. R. Doug McEvoy