The Effect of Orofacial Myofunctional Therapy With Autofeedback and the Effect of Anatomical and Behavioral Variables on Adherence to Orofacial Myofunctional Therapy in Patients With Mild or Moderate Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- Apnea hypopnea index reduction
研究概览
简要总结
The overall aim of this study is to estimate the effect of orofacial myofunctional therapy (OMT) plus auto-monitoring compared to auto-monitoring alone. Moreover, the investigators aim to identify anatomical and behavioural predictors of OMT adherence
详细描述
The overall aim will be addressed by reqruiting 100 participants to orofacial myofunctional therapy. 50 will be randomized to immediate treatment after the baseline consultation while 50 will get access to the treatment module after 3 monts of waiting. Outcomes will be assessed by a researcher blinded for the randomization result.
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 (Investigator, Outcomes Assessor)
盲法说明
Randomization is conducted at the end of the baseline assessment. Participants in the intervention group is handled by an OMT therapist until outcome assessment by the same postdoc student that did the baseline examination. The postdoc student has not been in contact with any participant during the intervention period.
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
- •Patients referred to Ahus or the Fertilitas clinic
- •A diagnosis of obstructive sleep apnea according to the current International Classsification of Sleep Disorders (ICSD) version 3 criteria {Berry, 2020, The AASM Manual for the Scoring of Sleep and Associated Events: Rules', Terminology and Technical Specifications', Version 2.6.;, 2014, International classification of sleep disorders', 3rd ed.}, with a respiratory event index (REI) <
- •Not previously or currently treated with PAP or MAD
- •Signed informed, written consent.
- •Owning a mobile phone with software compatible for the study application Age ≥18 year.
- •Body mass index <30
- •Ability to breathe through the nose
- •Ability to read and willingness to follow the protocol as described in the written consent form
- •Teeth 5-to 5 should be present or fixed by prosthesis or implants.
- •No botulinium toxin in facial muscles last three months
排除标准
- •Failure to fill in at least 70% of days in the electronic sleep diary provided in the mobile app for two weeks.
- •Medical or psychiatric conditions which may interfere with the study protocol in the opinion of the investigator. Examples are acute psychosis, drug abuse and dementia. This will be noted in the study inclusion-exclusion document for each approached candidate for the study. The information will then be discussed in an exlusion committee consisting of dr. Skirbekk, Jagomägi, Dammen and Hrubos-Strøm.
- •Tongue-tie as described below. Participants with mouth opening of <50% with the tip of the tongue at the incisive papilla compared to total mouth opening will be excluded.
结局指标
主要结局
Apnea hypopnea index reduction
时间窗: 3 months
Measured by self-applied somnography. The index represents number of apneas or hypopneas per hour from 0/h. Higher values represents more severe disease.
次要结局
- Change in desaturation severity parameter measured by medical device(3 months)
- Change in desaturation duration measured by medical device(3 months)
- Change in the Epworth Sleepines scale(3 months)
- Orofacial myofunctional therapy adherence(3 months)
- Change in objective sleep quality(3 months)
- Change in desaturation duration measured by wearable(3 months)
- Change in stroop test(3 months)
- Changes in tongue strength(3 months)
- Change in reaction test(3 months)
- Changes in tongue endurance(3 months)
- Change in memory test(3 months)
- Change general health status(3 months)
- Changes in the Orofacial Myofunctional Evaluation with Scores(3 months)
- Change in desaturation severity parameter measured by wearable(3 months)
- Change in perception test(3 months)
研究者
Harald Hrubos-Strøm
MD, PhD, senior consultant and head of research group, principal investigator
University Hospital, Akershus