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Mandibular Advancement Device for Obstructive Sleep Apnea

A Randomized Controlled Trial of a Mandibular Advancement Device for Obstructive Sleep Apnea

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00243139
Enrollment
90
Registered
2005-10-21
Start date
1999-07-31
Completion date
2004-02-29
Last updated
2006-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Sleep Apnea, Sleep Apnea Syndromes

Keywords

Oral appliances, Obstructive sleep apnea, Epworth Sleepiness Scale, SF-36

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.

Interventions

DEVICEMandibular advancement device (activator)

Sponsors

University of Copenhagen
CollaboratorOTHER
Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
CollaboratorUNKNOWN
Nykøbing Falster County Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Change in sleep parameters, especially apnea-hypopnea index (AHI).

Secondary

MeasureTime frame
Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
Change in quality of life, assessed by SF-36.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026