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

Completed

• Conditions: OSAS; Sleep apnea syndrome; 10046304

• Registration Number: NL-OMON41520
• Lead Sponsor: niversitair Medisch Centrum Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2017-12-31
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 86

Inclusion Criteria

1. Individuals with moderate (AHI 15-30) OSAS, measured during polysomnography
2. Aged >18 years

Exclusion Criteria

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).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured<br /><br>during polysomnography and quality adjusted life years (QALYs). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Polysomnographic outcomes: total sleep time, sleep efficiency, minimal<br /><br>oxyhemoglobin saturation, arousals, sleep stages; anthropometrical outcomes:<br /><br>BMI, waist and neck circumference, fat-free mass and fat percentage; objective<br /><br>and subjective side effects; neurobehavioral outcomes (by questionnaires): EDS,<br /><br>quality of life, anxiety and depression, activities of daily living,<br /><br>compliance, satisfaction; cardiovascular risk: smoking status, ambulant blood<br /><br>pressure measurements, blood samples, urine sample, accumulation of advanced<br /><br>glycation endproducts (AGEs) in skin tissue.</p><br>