MRA Therapy Versus CPAP Therapy in Moderate OSAS (REST)

May 14, 2018 updated by: Grietje E de Vries, MSc, University Medical Center Groningen

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3, 6 and 12 months
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
6 and 12 months
Change in polysomnographic outcomes
Time Frame: 3 and 12 months
total sleep time, sleep efficiency, minimal oxyhemoglobin saturation, arousals, sleep stages
3 and 12 months
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
3 and 12 months
Compliance
Time Frame: 3, 6 and 12 months
objective compliance by reading out devices subjective compliance by questionnaire
3, 6 and 12 months
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
3, 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Medical Center Groningen

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2012

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

December 31, 2017

Study Registration Dates

First Submitted

April 25, 2012

First Submitted That Met QC Criteria

April 27, 2012

First Posted (Estimate)

April 30, 2012

Study Record Updates

Last Update Posted (Actual)

May 15, 2018

Last Update Submitted That Met QC Criteria

May 14, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NL34138.042.10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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