MRA Therapy Versus CPAP Therapy in Moderate OSAS

Sleep Apnea, Obstructive Clinical Trial

— REST  

Official title:

Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01588275
• Other study ID #: NL34138.042.10
• Status: Completed
• Phase: N/A
• Start date: May 24, 2012
• Est. completion date: December 31, 2017

Study information

• Verified date: May 2018
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the cost-effectiveness and effectiveness of mandibular repositioning appliance (MRA) versus Continuous positive airway pressure (CPAP) therapy in patients with moderate Obstructive Sleep Apnea Syndrome (OSAS).

Description:

Study design: In a randomized parallel controlled study 86 patients will be randomly assigned to either MRA therapy or CPAP therapy. Group A receives MRA. Group B receives CPAP. The total duration of the study is 12 months. Measurements will be done at baseline, after 3, 6 and 12 months.

Intervention: Group A will be treated with a bibloc MRA (Somnodent). The mandible will be set at 70% of the patient's maximum advancement and will be adjusted to the convenience of the patient. Titration will be continued until symptoms abate or until further advancement causes discomfort.

Group B will be treated with CPAP. Proper CPAP-pressure will be set for each patient separately. Patients are fitted with a comfortable CPAP mask before titration of the CPAP-pressure. For CPAP-titration, patients are instructed to adopt their own typical sleeping habits.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• mandibular repositioning appliance (MRA) (SomnoDent)
bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula

Procedure:
• Continuous positive airway pressure (CPAP)
Proper CPAP-pressure will be set for each patient separately.

Locations

Country	Name	City	State
Netherlands	Martini Ziekenhuis Groningen	Groningen
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Medisch Centrum Leeuwarden	Leeuwarden	Fryslan

Sponsors (3)

Lead Sponsor	Collaborator
University Medical Center Groningen	SomnoMed Goedegebuure, VitalAire Nederland BV

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years	Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)	12 months
Secondary	Change in quality of life	EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months	3, 6 and 12 months
Secondary	Change in Cardiovascular risk	smoking status, change from baseline ambulant blood pressure measurements after 12 months, blood samples, urine sample, accumulation of advanced glycation endproducts (AGEs) in skin tissue	6 and 12 months
Secondary	Change in polysomnographic outcomes	total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages	3 and 12 months
Secondary	Change in activities of daily living	Total distance on 6 minutes walking test Number of steps measured with pedometer	3 and 12 months
Secondary	Compliance	objective compliance by reading out devices subjective compliance by questionnaire	3, 6 and 12 months
Secondary	Side effects	self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP	3, 6 and 12 months