MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)

This is an interventional treatment trial for Sleep Apnea, Obstructive focused on measuring cost-effectiveness, effectiveness, treatment, CPAP, MRA, compliance Read More

Inclusion Criteria:

• Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
• Aged ≥ 18 years;

Exclusion Criteria:

Medical and psychological criteria:

• Patients previously treated for OSAS (e.g. CPAP, MRA);
• Morphologic abnormalities of the upper airway (e.g., a compromised nasal passage, enlarged tonsils or adenoids, or upper airway soft-tissue or craniofacial abnormality);
• Reported or documented unstable endocrine dysfunction (hypothyroidism, acromegaly, or pituitary adenoma); Reported or documented severe cardiovascular- or pulmonary co-morbidity
• Clinically concurrent cardiovascular disease (coronary artery disease, heart failure,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.
• Reported or documented psychological condition precluding informed consent (e.g., mental retardation, depression or schizophrenia);

Whether the patient has unstable endocrine dysfunction, severe cardiovascular- or pulmonary co-morbidity or a psychological condition precluding informed consent, will be assessed by evaluating the patient's medical record.

Dental exclusion criteria:

• Extensive periodontal disease or tooth decay;
• Active temporomandibular joint disease (including severe bruxism);
• Restrictions in mouth opening (< 25mm) or advancement of the mandible <5mm);
• Partial or complete edentulism (less than eight teeth in upper or lower jaw).