Status:

COMPLETED

Mandibular Advancement Device for Obstructive Sleep Apnea

Lead Sponsor:

Nykøbing Falster County Hospital

Collaborating Sponsors:

University of Copenhagen

Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark

Conditions:

Sleep Apnea Syndromes

Sleep Apnea

Eligibility:

All Genders

21+ years

Phase:

PHASE2

PHASE3

Brief Summary

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 fin...

Detailed Description

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 sl...

Eligibility Criteria

Inclusion

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

Exclusion

  • sleep apnea with severe cardiovascular disease
  • other severe somatic or psychiatric disease
  • periodontal disease
  • significant occlusal dysfunction
  • pregnant women

Key Trial Info

Start Date :

July 1 1999

Trial Type :

INTERVENTIONAL

End Date :

February 1 2004

Estimated Enrollment :

90 Patients enrolled

Trial Details

Trial ID

NCT00243139

Start Date

July 1 1999

End Date

February 1 2004

Last Update

September 15 2006

Active Locations (1)

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1

Nykoebing Falster County Hospital

Nykoebing Falster, Storstrøms County, Denmark, DK-4800