MRA Therapy Versus CPAP Therapy in Moderate OSAS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-24

Study Completion Date

2017-12-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Sleep Apnea, Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

mandibular repositioning appliance (MRA) (SomnoDent)

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Continuous positive airway pressure (CPAP)

Intervention Type PROCEDURE

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

Interventions

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mandibular repositioning appliance (MRA) (SomnoDent)

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

Intervention Type DEVICE

Continuous positive airway pressure (CPAP)

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

Intervention Type PROCEDURE

Other Intervention Names

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bibloc SomnoDent

Eligibility Criteria

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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.

* 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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No