About this trial
Obstructive Sleep Apnea (OSA) is one of the most prevalent sleep disorders, affecting nearly one billion people worldwide. It is characterized by repeated episodes of complete (apnea) or partial (hypopnea) obstruction of the upper airway during sleep, leading to snoring, excessive daytime sleepiness, insomnia, morning headaches, nocturia, behavioral changes, reduced concentration, and serious cardiovascular and metabolic complications such as insulin resistance, type II diabetes, and metabolic syndrome. During the night, patients may experience up to a hundred apnea or hypopnea events lasting from 10 to 120 seconds. Therapy for OSA depends on its severity, defined by five or more obstructive events per hour of sleep. Over the past decade and a half, oral appliances (OAs) have become the treatment of choice for mild to moderate forms of OSA due to their efficacy and comfort. For this purpose, the DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) has been designed with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep. Unlike conventional OAs that fix the mandible in only one propulsive position, causing stress to orofacial complex and upper airway structures such as masticatory muscles and the temporomandibular joints, the DPOA provides gradual, automatic mandibular movement to the previously determined propulsive position. This gradual adaptation minimizes stress, reduces side effects, and enhances treatment success. In that way, the DPOA enables complete functional adaptation of the orofacial system and upper airway structures, leading to improved patient comfort and better therapeutic outcome.
The primary objective of the study is to determine the effectiveness of OSA therapy in patients with skeletal Class I (eugnathic jaw relationship) using a DYNAMIC PROPULSION ORAL APPLIANCE (DPOA) with a mechanism that provides controlled, gentle, gradual and automatic mandible movement in propulsion during sleep.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age between 20 and 65 years
clinically confirmed diagnosis of mild or moderate obstructive sleep apnea (Apnea hypopnea index 15-30 episodes/hour)
sufficient number of periodontally healthy teeth to support the oral appliance
written informed consent of conformance with the study protocol
Disqualifiers
age bellow 20 and over 65 years
patients not able or not willing to follow the study protocol
patients with severe OSA (Apnea hypopnea index > 30 episodes/hour) and/or some other breathing disturbances
patients with psychiatric, neurological or psychosomatic disorders
Trial design
Parallel
Treatments tested in this trial
dynamic propulsion oral appliance treatment (DPOA)
Deviceapplication of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase
elastic mandibular advancement appliance treatment
Devicetreatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase
Treatment groups
Trial outcomes
Primary outcomes
nasal airflow
measured by respiratory poligraphy (ml/min)
oxygen saturation
measured by respiratory poligraphy in the range 0-100%
heart rate
measured by respiratory poligraphy in the range 30 - 250 bpm
nasal air pressure
measured by respiratory poligraphy
Secondary outcomes
sleepness monitoring
measured by Epworth Sleepness Scale (a self-administered, 8-question survey measuring daytime sleepiness by rating the likelihood of dozing in common, sedentary situations; scores range from 0-24, with higher numbers indicating excessive daytime sleepiness)
snoring and breathing disruption during the sleep
measured by Berlin Questionnaire (snoring intensity, frequency, and witnessed apnea - questions Nr. 1 to Nr. 5, a positive score indicates a high risk of OSA
daily sleepiness monitoring
measured by Berlin Questionnaire (daytime sleepiness, fatigue, or nodding off while driving - questions Nr. 6 to Nr. 9, positive score indicates high risk of OSA)
presence of hypertension and/or obesity
measured by Berlin Questionnaire (History of high blood pressure (\>140/90) or Body Mass Index (BMI) \>30 kg/m2 - question 10)
Other outcomes
jaw functional limitation skill
monitoring the movement range of the lower jaw
masticatory muscles sensitivity
by the method of the palpation
gingival index
according to the Lou-Silness
plaque index
according to Silness-Lou
Sponsors and contacts
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