MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2016 by University Medical Center Groningen

Sponsor:

Collaborators:

VitalAire Nederland BV

SomnoMed Goedegebuure

Information provided by (Responsible Party):

Grietje E de Vries, MSc, University Medical Center Groningen

ClinicalTrials.gov Identifier:

NCT01588275

First received: April 25, 2012

Last updated: March 8, 2016

Last verified: March 2016

History of Changes

Purpose

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	Intervention
Sleep Apnea, Obstructive	Device: mandibular repositioning appliance (MRA) (SomnoDent) Procedure: Continuous positive airway pressure (CPAP)


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Sleep Apnea

U.S. FDA Resources

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:

Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction and quality adjusted life years [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Incremental cost-effectiveness ratio (ICER) in terms of AHI reduction measured during polysomnography and quality adjusted life years (QALYs)

Secondary Outcome Measures:

Change in quality of life [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
EQ5D, SF-36, FOSQ questionnaires at baseline and after 3, 6 and 12 months
Change in Cardiovascular risk [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
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
Change in polysomnographic outcomes [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
Change in activities of daily living [ Time Frame: 3 and 12 months ] [ Designated as safety issue: No ]
Total distance on 6 minutes walking test Number of steps measured with pedometer
Compliance [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
objective compliance by reading out devices subjective compliance by questionnaire
Side effects [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
self-reported side effects from device dental and maxillofacial side-effects from both MRA and CPAP


Estimated Enrollment:	86
Study Start Date:	March 2012
Estimated Study Completion Date:	July 2017
Estimated Primary Completion Date:	May 2017 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588275

Contacts


Contact: Grietje E de Vries, MSc	+31503619195	g.e.de.vries@umcg.nl
Contact: Peter J Wijkstra, PhD	+31503619353	p.j.wijkstra@umcg.nl

Locations


Netherlands
Medisch Centrum Leeuwarden	Recruiting
Leeuwarden, Fryslan, Netherlands, 8901 BR
Contact: de Vries g.e.de.vries@umcg.nl
University Medical Center Groningen	Recruiting
Groningen, Netherlands, 9700 RB
Contact: Grietje E de Vries, MSc +31503619195 g.e.de.vries@umcg.nl
Contact: Wijkstra p.j.wijkstra@umcg.nl
Sub-Investigator: Grietje E de Vries, MSc
Martini Ziekenhuis Groningen	Recruiting
Groningen, Netherlands, 9700 RM
Contact: de Vries g.e.de.vries@umcg.nl

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


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
Study First Received:	April 25, 2012
Last Updated:	March 8, 2016
Health Authority:	Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Center Groningen:


cost-effectiveness effectiveness treatment CPAP MRA

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

ClinicalTrials.gov processed this record on September 27, 2016

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