MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)

Study Description

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Brief 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).

Condition or disease	Intervention/treatment	Phase
Sleep Apnea, Obstructive	Device: mandibular repositioning appliance (MRA) (SomnoDent); Procedure: Continuous positive airway pressure (CPAP)	Not Applicable

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	86 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Cost-effectiveness of obstRuctivE Sleep Apnea Therapy (REST Study): Comparison of MRA Therapy Versus CPAP Therapy in Moderate OSAS
Actual Study Start Date :	May 24, 2012
Estimated Primary Completion Date :	December 2017
Estimated Study Completion Date :	December 2017

Arms and Interventions

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Arm	Intervention/treatment
Active Comparator: MRA therapy; During 12 months patients will be treated with a bibloc MRA (SomnoDent® MAS, SomnoMed Australia/Europe AG). The MRA will be customized by certified dentists or dental-specialists experienced in the field of dental sleep medicine.	Device: mandibular repositioning appliance (MRA) (SomnoDent); bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula; Other Name: bibloc SomnoDent
Active Comparator: CPAP therapy; During 12 months patients will be treated with Continuous positive airway pressure (CPAP).Treatment with CPAP prevents upper airway collapse by pneumatically "splinting" the upper airway during sleep.	Procedure: Continuous positive airway pressure (CPAP); Proper CPAP-pressure will be set for each patient separately.

Outcome Measures

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Primary Outcome Measures :

1. Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years [ Time Frame: 12 months ]
   Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)

Secondary Outcome Measures :

1. Change in quality of life [ Time Frame: 3, 6 and 12 months ]
   EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
2. Change in Cardiovascular risk [ Time Frame: 6 and 12 months ]
   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
3. Change in polysomnographic outcomes [ Time Frame: 3 and 12 months ]
   total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
4. Change in activities of daily living [ Time Frame: 3 and 12 months ]
   Total distance on 6 minutes walking test Number of steps measured with pedometer
5. Compliance [ Time Frame: 3, 6 and 12 months ]
   objective compliance by reading out devices subjective compliance by questionnaire
6. Side effects [ Time Frame: 3, 6 and 12 months ]
   self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

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Locations

Netherlands
Medisch Centrum Leeuwarden
Leeuwarden, Fryslan, Netherlands, 8901 BR
University Medical Center Groningen
Groningen, Netherlands, 9700 RB
Martini Ziekenhuis Groningen
Groningen, Netherlands, 9700 RM

Sponsors and Collaborators

University Medical Center Groningen

VitalAire Nederland BV

SomnoMed Goedegebuure

Investigators

Study Chair:	Grietje E de Vries, MSc	University Medical Center Groningen
Principal Investigator:	Peter J Wijkstra, PhD	University Medical Center Groningen

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Grietje E de Vries, MSc, researcher/project leader, University Medical Center Groningen
ClinicalTrials.gov Identifier:	NCT01588275 History of Changes
Other Study ID Numbers:	NL34138.042.10
First Posted:	April 30, 2012
Last Update Posted:	November 17, 2017
Last Verified:	November 2017

Keywords provided by Grietje E de Vries, MSc, University Medical Center Groningen:

cost-effectiveness; effectiveness; treatment	CPAP; MRA; compliance

Additional relevant MeSH terms:

Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Respiration Disorders; Respiratory Tract Diseases	Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases