The Impact Of Technology In The Myofunctional Therapy Treatment Of Obstructive Sleep Apnea Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Belun Ring Oxygen Saturation
研究概览
简要总结
This is a study to test if performing airway exercises to improve snoring and sleep apnea using a mobile phone app is better than using a hardcopy guide.
详细描述
Outcomes will be measured using tone analysis, snoring recording apps, and oximeters.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with mild, moderate, and severe OSA who rejected/failed CPAP or other therapeutic options will be invited to participate in the study.
排除标准
- •Age lower than 18 or higher than
- •Alcoholism or drug abuse
- •A-fib, pacemaker, CHF, strokes, narcotics
- •Neuromuscular disease
- •Use of benzodiazepine hypnotics (may affect muscle tone)
- •Restricted tongue movement
- •Permanently blocked nose
- •TMJ disorder.
- •Lost to follow-up
- •Gained or lost ≥5% of body weight during 3 months
研究组 & 干预措施
App Group
The mouth exercises are guided and tracked by a phone application.
干预措施: Exercise (Other)
Analog Group
The exercise and tracking is done using paper forms.
干预措施: Exercise (Other)
结局指标
主要结局
Belun Ring Oxygen Saturation
时间窗: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the average level of oxygen saturation in the blood, provided in a percentage outcome. .
Belun Ring lowest Oxygen Saturation Level
时间窗: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the lowest level of oxygen saturation recorded as a percentage.
Belun Ring Oxygen Saturation under 70%
时间窗: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter will provide the percentage of sleep that was under 70% SpO2.
Belun Ring AHI
时间窗: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter provides the Apnea/Hypopnea Index which is the number of apneic events per hour of sleep.
Belun Ring Pulse Rate
时间窗: baseline and then monthly for 3 months.
Oximeter with pulse rate registration. The oximeter provides the pulse rate as the average beats per minute with standard deviation, and range.
次要结局
- SnoreLab app(baseline and monthly for 3 months.)
- Tongue Elevation strength(baseline and monthly for 3 months.)
- Tongue Protrusion strength(baseline and monthly for 3 months.)
- Buccinator strength(baseline and monthly for 3 months.)
- STOP-Bang Questionnaire(baseline and monthly for 3 months.)
- Nasal Obstruction Assessment (NOSE) Questionnaire Score(baseline and monthly for 3 months.)
- PROMIS Sleep Disturbance 8b Short Form Questionnaire(baseline and monthly for 3 months.)
- Epworth Daytime Sleepiness Questionnaire(baseline and monthly for 3 months.)
- PROMIS Sleep Impairment 8a Short Form Questionnaire(baseline and monthly for 3 months.)