Mandibular Advancement Device for Obstructive Sleep Apnea
Primary Purpose
Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Mandibular advancement device (activator)
Sponsored by
About this trial
This is an interventional treatment trial for Sleep Apnea Syndromes focused on measuring Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36
Eligibility Criteria
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
Sites / Locations
- Nykoebing Falster County Hospital
Outcomes
Primary Outcome Measures
Change in sleep parameters, especially apnea-hypopnea index (AHI).
Secondary Outcome Measures
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Change in quality of life, assessed by SF-36.
Full Information
NCT ID
NCT00243139
First Posted
October 20, 2005
Last Updated
September 14, 2006
Sponsor
Nykøbing Falster County Hospital
Collaborators
University of Copenhagen, Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00243139
Brief Title
Mandibular Advancement Device for Obstructive Sleep Apnea
Official Title
A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Nykøbing Falster County Hospital
Collaborators
University of Copenhagen, Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
4. Oversight
5. Study Description
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 find factors for identification of those patients likely to benefit from this treatment.
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndromes, Sleep Apnea, Obstructive Sleep Apnea
Keywords
Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
90 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Mandibular advancement device (activator)
Primary Outcome Measure Information:
Title
Change in sleep parameters, especially apnea-hypopnea index (AHI).
Secondary Outcome Measure Information:
Title
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Title
Change in quality of life, assessed by SF-36.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Niels Petri, MD
Organizational Affiliation
Nykoebing Falster County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nykoebing Falster County Hospital
City
Nykoebing Falster
State/Province
Storstrøms County
ZIP/Postal Code
DK-4800
Country
Denmark
12. IPD Sharing Statement
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Mandibular Advancement Device for Obstructive Sleep Apnea
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