Respiratory Strength Training Mitigates Hypertension and Sleep Fragmentation in Obstructive Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Systolic and diastolic blood pressures (mmHg)
研究概览
简要总结
The purpose of the current study is to investigate the effects of a novel breathing training, called inspiratory muscle strength training (IMST), on sleep patterns, breathing and blood pressure for patients diagnosed with mild, moderate and severe sleep apnea.
详细描述
Aims of the study:
- To determine the influence of IMST on resting blood pressure and baroreceptor sensitivity.
- To determine the effect of IMST on sympathetic nervous system by measuring plasma cathecholamines and nerve recording (MSNA).
Population:
30 subjects aged 30-75 years, who have previously been diagnosed with obstructive sleep apnea, as defined by the National Institutes of Health (National Heart Lung, and Blood Institute) will be included in this study.
Study Protocol:
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
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 30-75 years
- •Diagnosed with Obstructive Sleep Apnea with Apnea Hypopnea Index (AHI) > 15
- •Neck circumference > 16 cm
排除标准
- •Body mass index (BMI) > 40kg/m2
- •Implanted pacemaker
- •On anticoagulant medication
- •On hypnotic medication
- •On immunosuppressive medication
- •Acute or recent (3 months prior to study) infection
- •History of hypothyroidism
- •History of stroke or neuromuscular disease
- •Moderate to severe heart failure
- •Severe ischemic heart disease
- •Severe obstructive and restrictive lung disease
- •Cor pulmonale
- •Cognitive disorders
- •Obstructive nasal disease or history of spontaneous pneumothorax or rib fracture
- •History of neurological, respiratory, head /neck, or thoracic surgery
研究组 & 干预措施
IMST Training Group
Subjects in inspiratory muscle strength training group will complete 30 breaths against a resistance set at 75% of Maximal Inspiratory Pressure (PI Max) everyday for period of 6 weeks.
干预措施: Inspiratory muscle strength training (Other)
Placebo Training Group
Subjects in placebo training group will complete 30 breaths against a resistance set at 15% of Maximal Inspiratory Pressure (PI Max) everyday for period of 6 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Systolic and diastolic blood pressures (mmHg)
时间窗: Weekly blood pressure measures obtained each week for 6 weeks
Blood pressure measured with blood pressure cuff and syphygmomanometer via standard auscultation technique.
次要结局
- Apnea hypopnea index(Prior to and upon completion of the 6-weeks respiratory strength training.)
- Sleep Quality Survey (PSQI)(Prior to and upon completion of the 6-weeks training.)
- Plasma cathecholamines (epinephrine, norepinephrine and dopamine)(Blood draw taken prior to and upon completion of the 6-weeks respiratory strength training.)
研究者
E. Fiona Bailey,PhD
Associate Professor
University of Arizona