Novel Myofunctional Water Bottle to Reduce OSA and Snoring Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Adherence to Therapy
研究概览
简要总结
This research study is being done to determine whether the repetition and resistance from the daily use of the myofunctional therapy (MT) nozzle will improve obstructive sleep apnea and primary snoring.
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 (Participant, Investigator)
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
- •Diagnosis of mild to moderate obstructive sleep apnea with Apnea Hypopnea Index 5-29 events/hour confirmed within last 2 years with an in-lab diagnostic polysomnography or home sleep apnea test.
- •Ownership of a smartphone and willingness to use a smartphone application to automatic log daily water intake.
- •Willingness and ability to discontinue the currently prescribed OSA treatment for at least 3 days prior to testing.
- •Age greater than or equal to 18 years.
- •Participants willing to travel to the Rochester area for the Speech and Language Pathologist exam
排除标准
- •Significant weight change (10% change in body weight in Kg) from the time of the OSA diagnosis until the study initiation.
- •Persistent excessive daytime sleepiness (Epworth Sleepiness scale > 10), despite treatment of OSA
- •Significant medical comorbidities requiring restricted oral fluid intake - decompensated heart failure, end stage renal disease, end stage liver disease, hyponatremia (S. Na <130 mg/dl), nocturia > times/night.
- •Significant mental health comorbidities including history of psychogenic polydipsia, obsessive-compulsive behavior, current suicidal ideation and uncontrolled anxiety.
- •Unable or unwilling to participate in study procedures.
- •Previous upper airway surgeries significantly modifying upper airway anatomy.
- •Known congenital or acquired diseases significantly affecting upper airway anatomy.
- •BMI >40 kg/m^
- •Currently treating OSA with hypoglossal nerve stimulator.
结局指标
主要结局
Adherence to Therapy
时间窗: 60 days
The was measured as the number of days subjects met their daily water consumption goal. Subjects were asked to hit their daily water consumption goal 5 days per week for 8 weeks.
Adherence to Therapy
时间窗: 60 days
The was measured as the number of days subjects met their daily water consumption goal. Subjects were asked to hit their daily water consumption goal 5 days per week for 8 weeks.
Change in Quality of Life
时间窗: Baseline, Day 60
Measured using the Calgary Sleep Apnea Quality of Life Index (SAQLI) questionnaire which assesses the quality of life in individuals with obstructive sleep apnea. It has a score between 1 and 7 on five different domains with total scores ranging from 7 to 42, with higher scores indicating a worse quality of life.
次要结局
- Change in Apnea Hypopnea Index (AHI)(Baseline, Day 60)
- Change in Myofunction Assessment(Baseline, Day 60)
- Change in Oxygen Saturation (SpO2)(Baseline; 60 Days)
- Change in Snoring Intensity(Baseline; Day 60)
- Change in Snoring Frequency(Baseline; Day 60)
研究者
Umesh Goswami
Principal Investigator
Mayo Clinic