The Effect of Occlusal Splints on Sleep and Respiratory Variables of OSA Patients
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value
研究概览
简要总结
Rationale: The effect of vertical dimension on sleep apnoea and respiratory variables in obstructive sleep apnoea patients.
Objective: To what extend should a possible worsening of the OSA condition, caused by an increase of mouth opening be taken into consideration in daily dental practice, when an occlusal stabilization splint (OSS) is placed in the mouth.
Study design: Cross over RCT-design Study population: OSA patients referred to ACTA from the Slotervaart Hospital, for treatment with a Mandibular Advancement Device (MAD), at least 18 years old.
Intervention: Occlusal stabilization splint (OSS) for the upper jaw and a controlled condition in a cross-over design Main study parameters/endpoints: Apnoea- Hypopnoea Index (AHI) and the Epworth Sleepiness Scale (ESS).
The aim of this study is to determine the effect of vertical dimension of OS on sleep and respiratory variables in OSA patients. The hypothesis is that insertion of an OSS and an increase of the vertical dimension will result in a significant increase in the AHI.
详细描述
Mild or Moderate OSA patients (AHI 10-30) referred by Slotervaart Hospital, to ACTA, for treatment with an MAD. Both males and females will participate in the study. All participants will be over 18 years old.
Inclusion criteria
- All patients invited should be at least 18 years old.
- OSA patients, diagnosis based on a baseline polysomnographic recording (at the hospital) with AHI values until 30 (mild+ moderate OSAS).
- Adequate retention in the dentition for an occlusal stabilization splint (OSS).
Exclusion criteria
- Medicine usage that influence sleep (eg Benzodiazepines).
- BMI more than 40
- Unhealthy dentition.
- Severe bruxers
- TMD patients An occlusal stabilization splint (OSS) will be constructed for each patient, as an intervention device. The splint will be a hard acrylic-resin stabilization appliance to wear in the upper jaw. The OSS does not come in contact with the gums of the patient and does not act as an orthodontic device. The OSS will be used only for the three nights in a row, of the ambulatory-PSG recording with the OSS in situ.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- All patients invited should be at least 18 years old.
- •OSA patients, diagnosis based on a baseline polysomnographic recording (at the hospital) with AHI values until 30 (mild+ moderate OSAS).
- •Adequate retention in the dentition for an occlusal stabilization splint (OSS).
排除标准
- •- Medicine usage that influence sleep (eg Benzodiazepines).
- •BMI more than 40
- •Unhealthy dentition.
- •Severe bruxers
- •TMD patients
结局指标
主要结局
The main study parameter/ endpoint is the Apnoea-Hypopnoea Index (AHI) value
时间窗: from all 6 nights
次要结局
- The secondary study parameter is the Epworth Sleepiness Scale (ESS)(from all 6 nights)