cost-effectiveness of obstRuctivE Sleep apnea Therapy (REST study): Comparison of MRA therapy versus CPAP therapy in moderate OSAS - REST study

niversitair Medisch Centrum Groningen0 个研究点目标入组 86 人开始时间: 待定最近更新: 2024年5月6日

适应症

试验速览

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•Medical and psychological criteria:
•1. Patients previously treated for OSAS (CPAP, MRA);
•2. Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality);
•3. Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma);
•4. Reported or documented severe cardiovascular- or pulmonary co-morbidity
•- coronary disease, heart failure, severe cardiac arrhythmias
•- CVA within 6 months prior to randomisation
•- daytime respiratory insufficiency
•- severe Chronic Obstructive Pulmonary Disease (COPD) (GOLD 3 or 4; FEV1/FVC<70% and FEV1 <50%);
•- other diseases that may impact the evaluation of the results of the study according to the investigator's judgement
•5. Reported or documented psychological condition precluding informed consent (e.g., mental retardation, depression or schizophrenia);;Dental exclusion criteria:
•1. Extensive periodontal disease or tooth decay;
•2. Active temporomandibular joint disease (including severe bruxism);
•3. Restrictions in mouth opening (<25mm) or advancement of the mandible <5mm);
•4. Partial or complete edentulism (less than eight teeth in upper or lower jaw).

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