NCT06153810已完成不适用
Efficacy of AesyBite Active in Reducing Sleep Bruxism Activity
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Aesyra SA
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Reduction of the bruxism activity
研究概览
简要总结
The overall objective of the clinical investigation is to evaluate whether the use of the AesyBite Active reduces the bruxism activity.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years, in good general health.
- •Presence of at least one of the following:
- •sleeping partner's report of tooth grinding sounds during sleep for at least three nights per week within the last 6 months,
- •hypertrophy of the masseter muscle upon digital palpation.
- •Presence of at least one of the following:
- •signs of tooth attrition or shiny spots on dental restorations,
- •self-report of masticatory muscle fatigue or pain at awakening.
- •Previous prescription of a night splint for bruxism.
- •Able to understand and follow the protocol and complete the self-administered paper questionnaires.
- •Able to provide written informed consent to study participation and storage and processing of study data
排除标准
- •Allergic to Ethylene-Vinyl Acetate (EVA) copolymer.
- •With more than two missing molars (excluding third molars).
- •Ongoing orthodontic treatment (e.g. teeth alignment).
- •With major neurological or psychiatric disorders including substance dependence.
- •Using a removable dental prosthesis.
- •Using a medication with known effects on sleep or motor behavior.
- •Suffering from periodontal disease.
- •With occlusal or jaw abnormalities that prevent the wearing of a normal dental splint.
- •Participants with pacemakers.
结局指标
主要结局
Reduction of the bruxism activity
时间窗: 1 month
Evaluation of the efficacy of AesyBite Active in reducing the bruxism activity expressed as total sleep bruxism duration per hour (TDPH, sec/hour) by at least 60% in the stimulation phase compared with baseline with a 10% non-inferiority margin.
次要结局
- Change in self-reported comfort marked on a visual analogue scale(1 month)
- Relative change in average intensity of bruxism episodes(1 month)
- Change in self-reported sleep quality marked on a visual analogue scale(1 month)
- Reduction of the bruxism index(1 month)
- Reduction of the mean duration of sleep bruxism episode(1 month)
- Change in self-reported retention marked on a visual analogue scale(1 month)
- Change in self-reported ease of breathing marked on a visual analogue scale(1 month)
- Change in self-reported pain marked on a visual analogue scale(1 month)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
The ABCs of SLEEPING: Effectiveness StudySleep ProblemsBehavioural Insomnia of ChildhoodNCT05072548IWK Health Centre172
已完成
不适用
Bioboosti Device for Insomnia TreatmentInsomniaNCT02924116Brigham and Women's Hospital20
终止
不适用
Juno Perth Clinical TrialRespiratory InsufficiencyObesity Hypoventilation SyndromeChronic Obstructive Pulmonary Disease (COPD)Neuromuscular DiseaseUpper Airway ObstructionNCT02317042ResMed25
已完成
不适用
Face of SleepinessObstructive Sleep ApneaNCT01060436University of Michigan30
已完成
不适用
Feasibility of Brief Behavioral Therapy for Insomnia (BBTI) in SUD RecoverySubstance Use DisordersInsomniaNCT05935735Johns Hopkins University83