Obstructive Sleep Apnea (OSA)NCT07414420
Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea
A study testing dynamic propulsion oral appliance treatment (DPOA) and elastic mandibular advancement appliance treatment in people with Obstructive Sleep Apnea (OSA), run by University of Belgrade at 1 site in Serbia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Obstructive Sleep Apnea (OSA)
- What is being tested?
- dynamic propulsion oral appliance treatment (DPOA) and elastic mandibular advancement appliance treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSerbia
- Study dates
- Mar 2026to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- patients with Body Mass Index > 29kg/sqm
- pregnancy
Show all 11Show fewer
- presence of the anatomical obstruction in the airways
- severe periodontal disease (III and IV grade)
- pathological changes in the structures of TMJ, muscles or ligaments
- mandibular protrusion less than 3mm
- orthodontic anomalies, malocclusions, II and III skeletal class, and orthodontic appliances
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Serbia1 site
University of Belgrade School of Dental Medicine
Belgrade, 11000
Vojkan Lazic, +381112685288, stomfak@afrodita.rcub.bg.ac.rs
Aleksandra Čairović
About this study
Official title: Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea
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.
- Conditions
- Obstructive Sleep Apnea (OSA)
- Being tested
- dynamic propulsion oral appliance treatment (DPOA), elastic mandibular advancement appliance treatment
- Keywords
- obstructive sleep apnea, oral apparatus
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dynamic propulsion oral appliance treatment (DPOA)Device
application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase
elastic mandibular advancement appliance treatmentDevice
treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | patients treated with dynamic oral appliance Receives: Device: dynamic propulsion oral appliance treatment (DPOA) |
| control | Active comparator | patients treated with Elastic Mandibular Advancement (EMA) appliance Receives: Device: elastic mandibular advancement appliance treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
nasal airflow
measured by respiratory poligraphy (ml/min)
Measured: prior to treatment and 3 months after the treatment initiation
oxygen saturation
measured by respiratory poligraphy in the range 0-100%
Measured: prior to treatment and 3 months after start of the treatment
heart rate
measured by respiratory poligraphy in the range 30 - 250 bpm
Measured: prior to treatment and 3 months after treatment initiation
nasal air pressure
measured by respiratory poligraphy
Measured: prior to the treatment and 3 months after the treatment initiation
toracal and abdominal strain
measured by respiratory poligraphy
Measured: prior to the treatment and 3 months after treatment initiation
audio recording of breathing and snoring
measured by respiratory poligraphy
Measured: prior to the treatment and 3 months after treatment initiation
body posture and activity
measured by pulmonary poligraphy
Measured: prior to the treatment and 3 months after the treatment initiation
Secondary outcomes (4)
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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: prior to the treatment and 3 months after the treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea (OSA)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marija S. Milic, University of Belgrade
- Investigators
- Aleksandra Čairović, DDS PhD, Principal investigator, University of Belgrade School of Dental MedicineLuka Župac, DDS, PhD student, Principal investigator, University of Belgrade School of dental MedicineMarija S Milic, DDS PhD, Principal investigator, University of Belgrade School of Dental Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07414420
- Sponsor's protocol ID
- 36/23
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study database with anonymised patient data is planned to be shared on the Zenodo or Figshare website
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea
- ClinicalTrials.gov ID
- NCT07414420
- Acronym / sponsor ID
- 36/23
- Conditions
- Obstructive Sleep Apnea (OSA)
- Keywords
- obstructive sleep apnea, oral apparatus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Device: dynamic propulsion oral appliance treatment (DPOA)patients treated with dynamic oral appliance |
| control | Active comparator | Device: elastic mandibular advancement appliance treatmentpatients treated with Elastic Mandibular Advancement (EMA) appliance |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
- patients with Body Mass Index > 29kg/sqm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dynamic propulsion oral appliance treatment (DPOA)application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase | Device | test group |
| elastic mandibular advancement appliance treatmenttreatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase | Device | control |
Primary outcome
nasal airflow
Time frame: prior to treatment and 3 months after the treatment initiation
measured by respiratory poligraphy (ml/min)
oxygen saturation
Time frame: prior to treatment and 3 months after start of the treatment
measured by respiratory poligraphy in the range 0-100%
heart rate
Time frame: prior to treatment and 3 months after treatment initiation
measured by respiratory poligraphy in the range 30 - 250 bpm
nasal air pressure
Time frame: prior to the treatment and 3 months after the treatment initiation
measured by respiratory poligraphy
toracal and abdominal strain
Time frame: prior to the treatment and 3 months after treatment initiation
measured by respiratory poligraphy
audio recording of breathing and snoring
Time frame: prior to the treatment and 3 months after treatment initiation
measured by respiratory poligraphy
body posture and activity
Time frame: prior to the treatment and 3 months after the treatment initiation
measured by pulmonary poligraphy
4 secondary outcomes
sleepness monitoring
Time frame: prior to the treatment and 3 months after the treatment initiation
snoring and breathing disruption during the sleep
Time frame: prior to the treatment and 3 months after the treatment initiation
daily sleepiness monitoring
Time frame: prior to the treatment and 3 months after the treatment initiation
presence of hypertension and/or obesity
Time frame: prior to the treatment and 3 months after the treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Individual participant dataSharing planned: Yes. The study database with anonymised patient data is planned to be shared on the Zenodo or Figshare website
Related trials for Obstructive Sleep Apnea (OSA)
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aleksandra Čairović, DDS PhD principal investigator
University of Belgrade School of Dental Medicine
Luka Župac, DDS, PhD student principal investigator
University of Belgrade School of dental Medicine
Marija S Milic, DDS PhD principal investigator
University of Belgrade School of Dental Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dynamic propulsion oral appliance treatment (DPOA) and elastic mandibular advancement appliance treatment in people with Obstructive Sleep Apnea (OSA), run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vojkan Lazić, DDS PhD, full professor (+381112685288, stomfak@afrodita.rcub.bg.ac.rs), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
nasal airflow (time frame: prior to treatment and 3 months after the treatment initiation). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.