An interventional study of dynamic propulsion oral appliance treatment (DPOA) and elastic mandibular advancement appliance treatment in Obstructive Sleep Apnea (OSA), sponsored by University of Belgrade. Not yet recruiting at 1 site in Serbia. Open to participants aged 20 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-02-18.
Sponsored by University of Belgrade · Not applicable, Interventional, and Treatment
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.
2,240 studies on the registry are indexed under Sleep Apnea, Obstructive; 475 are open to participants now.
This study's planned enrollment of 40 is below the median of 52 across 1,472 interventional studies indexed under Sleep Apnea, Obstructive.
Browse Sleep Apnea, Obstructive studies →University of Belgrade is the lead sponsor of 72 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients treated with dynamic oral appliance
Device: dynamic propulsion oral appliance treatment (DPOA)
patients treated with Elastic Mandibular Advancement (EMA) appliance
Device: elastic mandibular advancement appliance treatment
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
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
jaw functional limitation skill
monitoring the movement range of the lower jaw
Time frame: prior to the treatment and 3 months after the treatment initiation
masticatory muscles sensitivity
by the method of the palpation
Time frame: prior to the treatment and 3 months after the treatment initiation
gingival index
according to the Lou-Silness
Time frame: prior to the treatment and 3 months after the treatment initiation
plaque index
according to Silness-Lou
Time frame: prior to the treatment and 3 months after the treatment initiation
bleeding on probing
based on the number of bleeding spots around each tooth
Time frame: prior to the treatment and 3 months after the treatment initiation
probing pocket depth
Time frame: prior to the treatment and 3 months after the treatment initiation
Plan to share: Yes — The study database with anonymised patient data is planned to be shared on the Zenodo or Figshare website
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Sep 2027, 18 months later.
Of 508 non-industry interventional studies with no phase under Sleep Apnea, Obstructive, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 53. This study's planned 18 months is below that.
Counting every sponsor, half of 623 studies reached it within 27 months; a quarter within 12 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Belgrade