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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase
treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase
University of Belgrade School of Dental Medicine
Belgrade, Serbia
nasal airflow
measured by respiratory poligraphy (ml/min)
Time frame: prior to treatment and 3 months after the treatment initiation
oxygen saturation
measured by respiratory poligraphy in the range 0-100%
Time frame: prior to treatment and 3 months after start of the treatment
heart rate
measured by respiratory poligraphy in the range 30 - 250 bpm
Time frame: prior to treatment and 3 months after treatment initiation
nasal air pressure
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after the treatment initiation
toracal and abdominal strain
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after treatment initiation
audio recording of breathing and snoring
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after treatment initiation
body posture and activity
measured by pulmonary poligraphy
Time frame: prior to the treatment and 3 months after the treatment initiation
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)
Time frame: prior to the treatment and 3 months after the treatment initiation
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
Time frame: prior to the treatment and 3 months after the treatment initiation
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)
Time frame: prior to the treatment and 3 months after the treatment initiation
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)
Time frame: prior to the treatment and 3 months after the treatment initiation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.