University of Belgrade School of Dental Medicine
Belgrade, 11000, Serbia
Location contact
Aleksandra Čairović
PRINCIPAL_INVESTIGATOR
Luka Župac
PRINCIPAL_INVESTIGATOR
Marija S Milic, DDS PhD
PRINCIPAL_INVESTIGATOR
Vojkan Lazic
CONTACT
NCT Number: NCT07414420
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.
Trial opening soon.
Get Notified20 year–65 year
All sexes
Interventional
Not applicable
Belgrade, 11000, Serbia
Aleksandra Čairović
PRINCIPAL_INVESTIGATOR
Luka Župac
PRINCIPAL_INVESTIGATOR
Marija S Milic, DDS PhD
PRINCIPAL_INVESTIGATOR
Vojkan Lazic
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: prior to treatment and 3 months after the treatment initiation
measured by respiratory poligraphy (ml/min)
Time frame: prior to treatment and 3 months after start of the treatment
measured by respiratory poligraphy in the range 0-100%
Time frame: prior to treatment and 3 months after treatment initiation
measured by respiratory poligraphy in the range 30 - 250 bpm
Time frame: prior to the treatment and 3 months after the treatment initiation
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after treatment initiation
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after treatment initiation
measured by respiratory poligraphy
Time frame: prior to the treatment and 3 months after the treatment initiation
measured by pulmonary poligraphy
Time frame: prior to the treatment and 3 months after the treatment initiation
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
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
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
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
monitoring the movement range of the lower jaw
Time frame: prior to the treatment and 3 months after the treatment initiation
by the method of the palpation
Time frame: prior to the treatment and 3 months after the treatment initiation
according to the Lou-Silness
Time frame: prior to the treatment and 3 months after the treatment initiation
according to Silness-Lou
Time frame: prior to the treatment and 3 months after the treatment initiation
based on the number of bleeding spots around each tooth
Time frame: prior to the treatment and 3 months after the treatment initiation
Contact information is provided by the study sponsor or research team.
University of Belgrade
Other
Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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