Cost-effectiveness of Obstructive Sleep Apnea Therapy: Comparison of Mandibular Repositioning Appliance Therapy Versus CPAP Therapy in Moderate Obstructive Sleep Apnea Syndrome (REST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by University Medical Centre Groningen
Sponsor:
Collaborators:
ComCare Medical BV
Goedegebuure Slaaptechniek
Information provided by (Responsible Party):
Grietje E de Vries, MSc, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01588275
First received: April 25, 2012
Last updated: May 1, 2012
Last verified: May 2012
  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:


Further study details as provided by University Medical Centre 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: 100
Study Start Date: March 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MRA therapy 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 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 100 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
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, uvulopalatopharyngoplasty);
  • 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 Not yet recruiting
Leeuwarden, Fryslan, Netherlands, 8901 BR
Contact: de Vries       g.e.de.vries@umcg.nl   
Medisch Spectrum Twente Not yet recruiting
Enschede, Overijssel, Netherlands, 7500 KA
Contact: de Vries       g.e.de.vries@umcg.nl   
Martini Ziekenhuis Groningen Recruiting
Groningen, Netherlands, 9700 RM
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         
Sponsors and Collaborators
University Medical Centre Groningen
ComCare Medical BV
Goedegebuure Slaaptechniek
Investigators
Study Chair: Grietje E de Vries, MSc University Medical Centre Groningen
Principal Investigator: Peter J Wijkstra, PhD University Medical Centre Groningen
  More Information

No publications provided

Responsible Party: Grietje E de Vries, MSc, researcher/project leader, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01588275     History of Changes
Other Study ID Numbers: NL34138.042.10
Study First Received: April 25, 2012
Last Updated: May 1, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by University Medical Centre Groningen:
cost-effectiveness
effectiveness
treatment
CPAP
MRA

Additional relevant MeSH terms:
Sleep Apnea, Obstructive
Apnea
Sleep Apnea Syndromes
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on October 21, 2014