Clinical trial NCT00243139: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Sleep Apnea Syndromes
Sleep Apnea
Obstructive Sleep Apnea
Keywords: Oral appliances
Obstructive sleep apnea
Epworth Sleepiness Scale
SF-36
Lead sponsor: Nykøbing Falster County Hospital
Sponsor class: OTHER
Collaborators: name: University of Copenhagen
name: Center of Expertise, Oringe Psychiatric Hospital,Vordingborg, Denmark
First posted: 2005-10-21
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in sleep parameters, especially apnea-hypopnea index (AHI).
Secondary outcomes:
measure: Change in daytime sleepiness, assessed by Epworth Sleepiness Scale.
measure: Change in quality of life, assessed by SF-36.
Other outcomes:
Locations:
city: Nykoebing Falster
country: Denmark
facility: Nykoebing Falster County Hospital
state: Storstrøms County
Study officials:
affiliation: Nykoebing Falster County Hospital
name: Niels Petri, MD
role: PRINCIPAL_INVESTIGATOR
References: