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

Официальное название

Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea

Обзор

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.

Вмешательства

• Устройство dynamic propulsion oral appliance treatment (DPOA)
  application of dynamic propulsion oral appliance for the treatment of obstructive sleep apnea during the sleeping phase
• Устройство elastic mandibular advancement appliance treatment
  treatment of obstructive sleep apnea with elastic mandibular advancement appliance during the sleeping phase

Первичные конечные точки

• nasal airflow [Срок оценки: prior to treatment and 3 months after the treatment initiation]
• oxygen saturation [Срок оценки: prior to treatment and 3 months after start of the treatment]
• heart rate [Срок оценки: prior to treatment and 3 months after treatment initiation]
• nasal air pressure [Срок оценки: prior to the treatment and 3 months after the treatment initiation]
• toracal and abdominal strain [Срок оценки: prior to the treatment and 3 months after treatment initiation]
• audio recording of breathing and snoring [Срок оценки: prior to the treatment and 3 months after treatment initiation]
• body posture and activity [Срок оценки: prior to the treatment and 3 months after the treatment initiation]

Вторичные конечные точки (4)

• sleepness monitoring [Срок оценки: prior to the treatment and 3 months after the treatment initiation]
• snoring and breathing disruption during the sleep [Срок оценки: prior to the treatment and 3 months after the treatment initiation]
• daily sleepiness monitoring [Срок оценки: prior to the treatment and 3 months after the treatment initiation]
• presence of hypertension and/or obesity [Срок оценки: prior to the treatment and 3 months after the treatment initiation]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Сербия · 1 центр

• University of Belgrade School of Dental Medicine — Belgrade

Идентификаторы

NCT: NCT07414420 · 36/23

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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