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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorUniversity of Belgrade

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 treatment

    Device

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: test groupExperimental treatment 1 intervention
Group B: controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

nasal airflow

measured by respiratory poligraphy (ml/min)

Time frame
prior to treatment and 3 months after the treatment initiation
2

oxygen saturation

measured by respiratory poligraphy in the range 0-100%

Time frame
prior to treatment and 3 months after start of the treatment
3

heart rate

measured by respiratory poligraphy in the range 30 - 250 bpm

Time frame
prior to treatment and 3 months after treatment initiation
4

nasal air pressure

measured by respiratory poligraphy

Time frame
prior to the treatment and 3 months after the treatment initiation

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

1

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
2

masticatory muscles sensitivity

by the method of the palpation

Time frame
prior to the treatment and 3 months after the treatment initiation
3

gingival index

according to the Lou-Silness

Time frame
prior to the treatment and 3 months after the treatment initiation
4

plaque index

according to Silness-Lou

Time frame
prior to the treatment and 3 months after the treatment initiation

Sponsors and contacts

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