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Mandibular Advancement Device for Obstructive Sleep Apnea

NCT ID: NCT00243139

Last Updated: 2006-09-15

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

PHASE2/PHASE3

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-07-31

Study Completion Date

2004-02-29

Brief Summary

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The purpose of this study was to determine how effective a custom-made standard dental splint (activator) advancing the lower jaw forward is in treatment of obstructive sleep apnea, and further to find factors for identification of those patients likely to benefit from this treatment.

Detailed Description

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Obstructive sleep apnea (OSA) is far the most common sleep disordered breathing, affecting 2-4% of the adult population. The repetitive obstructions are located in the pharyngeal airway, leading to sleep fragmentation and resulting in excessive daytime sleepiness with consequences for ability to work, road safety and quality of life. Furthermore, OSA is an independant riskfactor for cardiovascular disease. The treatment of choice today is continuous positive airway pressure (CPAP) but a main problem with CPAP is an unsatisfactory compliance. An alternative conservative more user-friendly treatment could be oral appliances, intending to increase the pharyngeal airway directly by tongue retaining devices or indirectly by mandibular advancing devices. Though several randomized studies on oral appliances have come recent years, all giving some evidence for effect on OSA, they all had some shortcomings, such as using crossover design, small sample sizes, under-reporting of methods and data and lack of blinding.

In this study of a mandibular advancement device was used a parallel group design with an inactive device and no intervention as controls. Beside the effect on sleep, daytime sleepiness and quality of life, the study aimed to find objective factors to be used as predictors of the outcome.

Conditions

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Sleep Apnea Syndromes Sleep Apnea Obstructive Sleep Apnea

Keywords

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Oral appliances Obstructive sleep apnea Epworth Sleepiness Scale SF-36

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Mandibular advancement device (activator)

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* AHI \> 5 on polysomnography
* sufficient set of teeth to hold a splint
* written informed consent

Exclusion Criteria

* sleep apnea with severe cardiovascular disease
* other severe somatic or psychiatric disease
* periodontal disease
* significant occlusal dysfunction
* pregnant women
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Copenhagen

OTHER

Sponsor Role collaborator

Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark

UNKNOWN

Sponsor Role collaborator

Nykøbing Falster County Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Niels Petri, MD

Role: PRINCIPAL_INVESTIGATOR

Nykoebing Falster County Hospital

Locations

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Nykoebing Falster County Hospital

Nykoebing Falster, Storstrøms County, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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SNB01

Identifier Type: -

Identifier Source: org_study_id