Therapy-efficacy of automatic positive airways pressure therapy with A-Flex compared to standard automatic positive airways pressure therapy in obstructive sleep apnoea (OSA) patients

Respironics International Inc. (France)0 个研究点目标入组 40 人开始时间: 2008年5月15日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Apnoea-Hypopnoea Index (AHI) greater than 15/h confirmed by full polysomnograph (PSG)
•2. Aged greater than or equal to 21 to less than or equal to 65 years, either sex
•3. Body mass index (BMI) less than 40 kg/m^2
•4. Able to follow the study protocol

•1. Acute upper respiratory infection, encephalitis, sinusitis or middle ear infection
•2. Drug abuse
•3. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
•4. Alcohol abuse
•5. Psychiatric or neurological diseases resulting in impairment of sleep, therapy or compliance
•6. Thyroidal dysfunction
•7. Chronic pain syndromes
•8. Acute cardiac, pulmonary, and other internal diseases
•9. Chronic cardiac, pulmonary and other internal diseases resulting in impairment of sleep
•10. Central sleep related breathing disorders or other disorders resulting in hypoventilation
•11. Periodic leg movements (PLM)/restless legs syndrome (RLS)
•12. Previous exposure to either continuous positive airways pressure (CPAP) or bi-level therapy
•13. Patients experiencing acute dermatitis or other skin lesions or trauma interfering with the application of a mask
•14. Participation in another clinical study in the past four weeks

发起方

Respironics International Inc. (France)