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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41520

Enrollment

Registered

2011-07-13

Start date

2012-05-03

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OSAS Sleep apnea syndrome

Interventions

Patients in group A are treated with a bibloc MRA (SomnoDent). It positions the patients mandible in a forward and downward position thereby *stretching* the upper airway. The mandible will be set a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs).	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)