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MRA Therapy Versus CPAP Therapy in Moderate OSAS

NCT01588275 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2018-05-15

No results posted yet for this study

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).

Conditions

  • Sleep Apnea, Obstructive

Interventions

DEVICE

mandibular repositioning appliance (MRA) (SomnoDent)

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

PROCEDURE

Continuous positive airway pressure (CPAP)

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

Sponsors & Collaborators

  • VitalAire Nederland BV

    collaborator UNKNOWN

  • SomnoMed Goedegebuure

    collaborator UNKNOWN

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Grietje E de Vries, MSc · University Medical Center Groningen

  • Peter J Wijkstra, PhD · University Medical Center Groningen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-24
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01588275 on ClinicalTrials.gov