Treatment Effects of Oral Dynamic Propulsion Appliance During the Sleeping Phase in Patients With Obstructive Sleeping Apnea
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
- 否
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
patients treated with dynamic oral appliance
干预措施: dynamic propulsion oral appliance treatment (DPOA) (Device)
control
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
Marija S. Milic
DDS PhD, Assistant Professor
University of Belgrade
