Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapy

niversity Medical Center Groningen (The Netherlands)0 个研究点目标入组 102 人开始时间: 2005年9月12日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•Newly diagnosed OSAHS patients (over 20 years old) (i.e. criterion 1 and/or 2, plus criterion 3):
•1. Excessive daytime sleepiness that is not better explained by other factors (Epworth Sleepiness Scale more than or equal to ten)
•2. Two or more of the following symptoms that are not better explained by other factors:
•a. choking or gasping during sleep
•b. recurrent awakenings from sleep
•c. unrefreshing sleep
•d. daytime fatigue
•e. impaired concentration
•3. Overnight monitoring demonstrating an Apnea-Hypopnea Index (AHI) more than five

•1. Patients previously treated by:
•c. uvulopalatopharyngoplasty
•2. Morphological upper airway abnormalities requiring treatment:
•a. compromised nasal passage
•b. enlarged tonsils/ adenoids
•c. soft tissue- or craniofacial abnormalities in upper airway
•d. upper airway neoplasm
•3. Endocrine dysfunction:
•a. acromegaly
•b. hypothyrodism
•4. Co-morbidity:
•a. daytime respiratory insufficiency
•b. severe Chronic Obstructive Pulmonary Disease (COPD) (Forced Expriatory Volume in one second (FEV1)/Vital Capacity (VC) less than 40%)
•c. left ventricular failure
•d. severe daytime cardiac arrhythmias
•5. Psychological condition precluding informed consent:
•a. psychiatric diseases (eg depression, schizofrenia)
•b. mental retardation
•II. Dental exclusion criteria:
•1. Severe periodontal disease or dental decay
•2. 'Active' temporomandibular joint disease (including severe bruxism)
•3. Restrictions in mandibular opening or protrusion capacity:
•a. mouth opening less than 25 mm
•b. maximal protrusion mandible less than 5 mm
•4. Partial or complete edentulism:
•a. Less than eight teeth in upper or lower jaw
•III. Patients declining written informed consent

发起方

niversity Medical Center Groningen (The Netherlands)