NCT01588275

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 25, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
24 days until next milestone

Study Start

First participant enrolled

May 24, 2012

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

5.6 years

First QC Date

April 25, 2012

Last Update Submit

May 14, 2018

Conditions

Sleep Apnea, Obstructive

Keywords

cost-effectivenesseffectivenesstreatmentCPAPMRAcompliance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in quality of life

    3, 6 and 12 months

  • Change in Cardiovascular risk

    6 and 12 months

  • Change in polysomnographic outcomes

    3 and 12 months

  • Change in activities of daily living

    3 and 12 months

  • Compliance

    3, 6 and 12 months

  • +1 more secondary outcomes

Study Arms (2)

MRA therapy

ACTIVE COMPARATOR

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)

CPAP therapy

ACTIVE COMPARATOR

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)

Interventions

mandibular repositioning appliance (MRA) (SomnoDent)DEVICE

bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula

Also known as: bibloc SomnoDent
MRA therapy
Continuous positive airway pressure (CPAP)PROCEDURE

Proper CPAP-pressure will be set for each patient separately.

CPAP therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals who have been subjected to polysomnography and are diagnosed as having moderate (AHI 15-30) OSAS;
  • Aged ≥ 18 years;

You may not qualify if:

  • 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.
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Medisch Centrum Leeuwarden

Leeuwarden, Provincie Friesland, 8901 BR, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Martini Ziekenhuis Groningen

Groningen, 9700 RM, Netherlands

Location

Related Publications (3)

  • Uniken Venema JAM, Knol-de Vries GE, van Goor H, Westra J, Hoekema A, Wijkstra PJ. Cardiovascular and metabolic effects of a mandibular advancement device and continuous positive airway pressure in moderate obstructive sleep apnea: a randomized controlled trial. J Clin Sleep Med. 2022 Jun 1;18(6):1547-1555. doi: 10.5664/jcsm.9908.

    PMID: 35088708DERIVED

  • de Vries GE, Hoekema A, Claessen JQPJ, Stellingsma C, Stegenga B, Kerstjens HAM, Wijkstra PJ. Long-Term Objective Adherence to Mandibular Advancement Device Therapy Versus Continuous Positive Airway Pressure in Patients With Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Nov 15;15(11):1655-1663. doi: 10.5664/jcsm.8034.

    PMID: 31739856DERIVED

  • de Vries GE, Hoekema A, Vermeulen KM, Claessen JQPJ, Jacobs W, van der Maten J, van der Hoeven JH, Stegenga B, Kerstjens HAM, Wijkstra PJ. Clinical- and Cost-Effectiveness of a Mandibular Advancement Device Versus Continuous Positive Airway Pressure in Moderate Obstructive Sleep Apnea. J Clin Sleep Med. 2019 Oct 15;15(10):1477-1485. doi: 10.5664/jcsm.7980.

    PMID: 31596213DERIVED

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient Compliance

Interventions

Magnetic Resonance AngiographyContinuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Magnetic Resonance ImagingTomographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisAngiographyDiagnostic Techniques, CardiovascularPositive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Grietje E de Vries, MSc

    University Medical Center Groningen

    STUDY CHAIR

  • Peter J Wijkstra, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
researcher/project leader

Study Record Dates

First Submitted

April 25, 2012

First Posted

April 30, 2012

Study Start

May 24, 2012

Primary Completion

December 31, 2017

Study Completion

December 31, 2017

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

NL(3)