Oral Dynamic Propulsion Appliance in Treatment of Patients With Obstructive Sleeping Apnea

NCT07414420 | Not Yet Recruiting

• 1 other identifier: 36/23
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 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)

Keywords

obstructive sleep apnea, oral apparatus

Outcome Measures

Primary Outcomes (7)

• nasal airflow

  measured by respiratory poligraphy (ml/min)

  prior to treatment and 3 months after the treatment initiation

• oxygen saturation

  measured by respiratory poligraphy in the range 0-100%

  prior to treatment and 3 months after start of the treatment

• heart rate

  measured by respiratory poligraphy in the range 30 - 250 bpm

  prior to treatment and 3 months after treatment initiation

• nasal air pressure

  measured by respiratory poligraphy

  prior to the treatment and 3 months after the treatment initiation

• toracal and abdominal strain

  measured by respiratory poligraphy

  prior to the treatment and 3 months after treatment initiation

• audio recording of breathing and snoring

  measured by respiratory poligraphy

  prior to the treatment and 3 months after treatment initiation

• body posture and activity

  measured by pulmonary poligraphy

  prior to the treatment and 3 months after the treatment initiation

Secondary Outcomes (4)

• sleepness monitoring

  prior to the treatment and 3 months after the treatment initiation

• snoring and breathing disruption during the sleep

  prior to the treatment and 3 months after the treatment initiation

• daily sleepiness monitoring

  prior to the treatment and 3 months after the treatment initiation

• presence of hypertension and/or obesity

  prior to the treatment and 3 months after the treatment initiation

Other Outcomes (6)

• jaw functional limitation skill

  prior to the treatment and 3 months after the treatment initiation

• masticatory muscles sensitivity

  prior to the treatment and 3 months after the treatment initiation

• gingival index

  prior to the treatment and 3 months after the treatment initiation

Study Arms (2)

test group

EXPERIMENTAL

patients treated with dynamic oral appliance

Device: dynamic propulsion oral appliance treatment (DPOA)

control

ACTIVE COMPARATOR

patients treated with Elastic Mandibular Advancement (EMA) appliance

Device: elastic mandibular advancement appliance treatment

Interventions

dynamic propulsion oral appliance treatment (DPOA) DEVICE

application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase

test group

elastic mandibular advancement appliance treatment DEVICE

treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase

control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Belgrade: lead

Study Sites (1)

University of Belgrade School of Dental Medicine

Belgrade, 11000, Serbia

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Aleksandra Čairović, DDS PhD

  University of Belgrade School of Dental Medicine

  PRINCIPAL INVESTIGATOR

• Luka Župac, DDS, PhD student

  University of Belgrade School of dental Medicine

  PRINCIPAL INVESTIGATOR

• Marija S Milic, DDS PhD

  University of Belgrade School of Dental Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vojkan Lazić, DDS PhD, full professor

CONTACT

+381112685288; stomfak@afrodita.rcub.bg.ac.rs

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS PhD, Assistant Professor

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)