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临床试验/NCT07414420
NCT07414420尚未招募不适用

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

University of Belgrade1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2026年3月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
试验地点
1
主要终点
heart rate

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

test group

Experimental

patients treated with dynamic oral appliance

干预措施: dynamic propulsion oral appliance treatment (DPOA) (Device)

control

Active Comparator

patients treated with Elastic Mandibular Advancement (EMA) appliance

干预措施: elastic mandibular advancement appliance treatment (Device)

结局指标

主要结局

heart rate

时间窗: prior to treatment and 3 months after treatment initiation

measured by respiratory poligraphy in the range 30 - 250 bpm

nasal air pressure

时间窗: prior to the treatment and 3 months after the treatment initiation

measured by respiratory poligraphy

toracal and abdominal strain

时间窗: prior to the treatment and 3 months after treatment initiation

measured by respiratory poligraphy

audio recording of breathing and snoring

时间窗: prior to the treatment and 3 months after treatment initiation

measured by respiratory poligraphy

body posture and activity

时间窗: prior to the treatment and 3 months after the treatment initiation

measured by pulmonary poligraphy

nasal airflow

时间窗: prior to treatment and 3 months after the treatment initiation

measured by respiratory poligraphy (ml/min)

oxygen saturation

时间窗: prior to treatment and 3 months after start of the treatment

measured by respiratory poligraphy in the range 0-100%

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marija S. Milic

DDS PhD, Assistant Professor

University of Belgrade

研究点 (1)

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