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临床试验/NCT02259660
NCT02259660已完成不适用

Upper Airway Muscle Training for Obstructive Sleep Apnea

University of Florida2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2015年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
Apnea Hypopnea Index (AHI)

研究概览

简要总结

The purpose of this research study is to determine if muscle training will improve snoring and obstructive sleep apnea. Subjects will receive a sleep study to determine the severity of their apnea. After this study, subjects will be randomly assigned to one of two groups. The first group will receiving a breathing trainer that may strengthen the muscles used to breath in and out. The second group will be receive a sham trainer which looks like the "real" trainer but is not able to produce a strengthening effect. Both groups will complete eight weeks of home based (real or sham) training. The sleep study will be repeated and we well measure any changes in measures of severity for obstructive sleep apnea.

详细描述

Obstructive sleep apnea (OSA) is a common disorder characterized by intermittent narrowing or closure of the upper airway during sleep. Loss of muscle tone with sleep onset and decreases in ventilatory drive following the loss of the wakefulness stimuli to breathe combine to result in upper airway closure in patients with structurally susceptible upper airways. We hypothesize that training of upper airway muscles will improve sleep apnea by augmenting the resting upper airway muscle tone and ability of the muscles to respond to negative intraluminal pressure. Training with a primitive wind instrument (such as a Digeridoo) and oral pharyngeal exercises (OPE) used in speech therapy have been shown to improve sleep apnea. Individuals who play certain types of wind instruments appear to have a lower risk of sleep apnea. However, to date the mechanism of improvement and the optimal method of upper airway training have not been well defined. We recently completed a study with a facial exerciser (Facial Flex) designed to improve facial muscle tone and found a decrease in snoring in a group with loud snoring but minimal sleep apnea. A group of UF physiologists (including co investigators Drs. Davenport and Silverman) have also demonstrated that brief periods of training with high inspiratory and/or expiratory threshold loads improved cough and swallowing in patients with impairment in upper airway function. Although respiratory pump muscles provide the driving force for pressure generation during training with pressure threshold loads, the upper airway muscle must maintain a patent upper airway resisting high negative or positive intraluminal pressures. For example, the palate must maintain a seal preventing air escape through the nose when high positive pressure is generated through a mouthpiece. Of interest a limited number of very high intensity efforts appears to be the optimal way to train muscles.

We propose targeting a group of mild to moderate OSA patients (apnea-hypopnea index < 30/hour) who are not severely obese (BMI < 35 Kg/M2) and do not have significant structural abnormalities of the upper airway or muscle dysfunction. We will perform a randomized controlled trial (training versus sham training) with 25 subjects in each treatment arm using two months of daily training (5 out of 7 days each week). A home sleep study (including EEG) will be performed before and following the training. The change in the apnea-hypopnea index adjusted for sleep stage and body position will be compared. Use of home sleep studies will dramatically reduce the cost of the study. A sleep technologist will educate subjects on performance of maneuvers and meet with them weekly to observe the subject's technique. A training log will be kept by the subjects using training schedule sheets and daily training will be monitored through weekly web-based communication with a study clinician.

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
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years,
  • AHI ≥ 5/hour and less than 30/hour
  • Ability to understand and perform training.
  • Ability to return to the UFHealth Sleep Center 1X per week for the (8 week) duration of the study.

排除标准

  • Pregnancy
  • Prior Upper airway surgery (nasal surgery is allowed)
  • Severe nasal obstruction
  • BMI > 35 kg/M2
  • Use of potent narcotics
  • History of arrhythmia (other than PACs and PVCs)
  • Coronary artery disease or congestive heart failure (patients with controlled hypertension will be included),
  • Moderate to severe lung disease
  • History of pneumothorax.
  • severe daytime sleepiness (falling asleep while driving or
  • Epworth Sleepiness Scale [Appendix 1] > 14),
  • History of chronic short sleep duration (< 5 hours).

研究组 & 干预措施

Active Group

Active Comparator

Subjects in this arm will train their respiratory muscles at home. The training protocol will use progressively higher pressure threshold training valves to provide respiratory muscle strength training at a pressure threshold greater than 70% maximum inspiratory (MIP) and expiratory (MEP) pressures. The total daily training time should be 20 to 30 minutes in duration.

干预措施: Respiratory muscle strength training (Device)

Sham Training

Placebo Comparator

The intervention in the sham training arm will be identical in every way to that of the active arm with the exception of the trainer that is provided. Subjects in the sham training arm will have inspiratory and expiratory muscle strength trainers which have had the pressure threshold spring removed and are therefore unable to provide a load to the muscles being trained.

干预措施: Sham respiratory muscle strength training (Device)

结局指标

主要结局

Apnea Hypopnea Index (AHI)

时间窗: Baseline and 10 weeks

The AHI is a measure of symptom severity for obstructive sleep apnea. Physiological data obtained during a sleep study is used to complete this measure.

次要结局

  • Maximum expiratory pressure (MEP)(Baseline and 10 weeks)
  • Maximum inspiratory pressure (MIP)(Baseline and 10 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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