Evaluation of the Effectiveness of Direct to Consumer Mandibular Advancement Devices as an Adjunct for the Treatment of Mild to Moderate Obstructive Sleep Apnoea (OSA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Epworth sleepiness score (ESS)
研究概览
简要总结
Use of mandibular advancement devices(MADs) in the treatment of Obstructive Sleep Apnea is established, however this is hampered by high costs, long wait times and non-assured success in the local Asian setting. There are few studies which look at the use of prefabricated thermoplastic mandibular devices with a titratable component and its efficacy. In addition, it is direct-to-consumer and an economical option, thus there may be a role in the use of such devices to better select patients who may benefit and are thinking of using MADs.
The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success in an Asian population.
详细描述
Mandibular advancement devices (MAD) serve as an adjunct to the treatment of snoring as well as mild-moderate OSA. It is widely accepted that upper airway muscle activity decreases during sleep, leading to increased collapsibility of the pharyngeal tissues, mandibular opening and posterior displacement of the tongue. These changes result in narrowing of the oropharyngeal and hypopharyngeal airway (Hudgel 1992). Their primary action is to advance the mandible and tongue to increase the upper airway size. Recent systemic review on the effectiveness of MAD in treating OSA by Torres et al in the Laryngoscope showed that 16 out of 18 large scale studies showed significant improvement in Apnea-Hypopnea index (AHI).
There are a wide variety of MAD commercially available and they can be broadly divided into custom made vs prefabricated makes as well as titratable versus non-titratable types. It is shown that custom made, titratable fitted MADs are superior in efficacy as compared to their counterpart models. However, high cost, delayed waiting times and multiple clinic visits are required for patients to be fitted with custom MADs by a professional orthodontist. Newly developed direct to consumer thermoplastic MADs (MyTap) brings the benefit of mouldable bite and form "custom" fit with the option of titration to the user at a lower cost, technical ease of use and fit in the clinic setting.
Participants who are diagnosed with simple snoring or mild to moderate OSA are able to trial use thermoplastic MADs to have a sense of the level of comfort and effectiveness MAD can bring to improve their OSA, serving as a bridging device prior to committing to the use of custom made MAD.
The investigators aim to evaluate the effectiveness of the use of Prefabricated adjustable thermoplastic mandibular advancement devices(PAT-MADs)(MyTAP) in the treatment of OSA and its role for predicting treatment success, compliance and comfort in an Asian population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18years old and above
- •English competency
- •Formal diagnosis of mild-moderate OSA on PSG
- •Ability to provide informed consent
排除标准
- •diagnosed severe OSA
- •evidence of central sleep apnea events
- •dental conditions which preclude proper use of the MAD
- •treatment with other devices (e.g. tongue retainers, PAP therapy)
- •pregnancy
- •known allergic reactions to the components of the study product were excluded from the trial.
研究组 & 干预措施
Intervention group
prospective, single armed, single centre trial study using the MyTAP device on a daily basis for a period of 3 months
干预措施: mandibular advancement device (Device)
结局指标
主要结局
Epworth sleepiness score (ESS)
时间窗: 3 months
Epworth sleepiness score measures the level of sleepiness in a participant. Minimum value of 0 to a maximum level of 24, whereby the higher the value, the sleepier the participant.
Pittsburgh sleep quality index (PSQI)
时间窗: 3 months
Quality of life survey made up of 19 self rated questions which assesses the quality of 7 different aspects of sleep in participants with sleep disorders. Minimum value is 0 and maximum value is 21, where the higher the global value, the more severe the difficulties in different aspects of sleep.
Apnea-Hypopnea Index (AHI)
时间窗: 3 months
apnea-hypopnea index
Oxygen disturbance index (ODI)
时间窗: 3 months
Oxygen disturbance index
Lowest oxygen saturation (Lsat)
时间窗: 3 months
Lowest oxygen saturation
Apnea index (AI)
时间窗: 3 months
apnea index
Hypopnea index (HI)
时间窗: 3 months
Hypopnea index
Abbreviated functional outcomes of sleep questionnaire (FOSQ-10)
时间窗: 3 months
Quality of life survey made of up 10 self rated questions which assess the quality of sleep in participants with sleep disorders. Minimum value is 0 and maximum value is 40, where the lower the global value, the worse off the quality of sleep.
次要结局
- Predicting future use(3 months)