Extracellular Micro RNA (miR) (Extracellular Vesicle (EV)-Associated & Non-EV-associated miRs) Identify and Mediate Endothelial Dysfunction in Obesity and Obstructive Sleep Apnea in Adolescents & Young Adults
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Peripheral Arterial Tonometry - Reactive Hyperemic Index
研究概览
简要总结
Using a prospective observational approach and a clinical trial design comparing the effectiveness of continuous positive airway pressure to diet and exercise, investigators plan to evaluate how obstructive sleep apnea (OSA) leads to endothelial dysfunction in adolescents and young adults and whether treatment of OSA can improve endothelial dysfunction. Concurrently, investigators will measure miR 92a/miR 210 levels in all subjects at baseline and following therapy to determine whether miR 92a/miR 210 levels reliably predict endothelial dysfunction in patients and responses to therapy.
详细描述
Investigators will randomize 100 OSA patients (age 13-21) to receive either continuous positive airway pressure (CPAP) plus baseline diet/exercise (n=50) or medical management (intensive diet and exercise; n=50). Only children in whom adenotonsillectomy is contraindicated (morbid obesity, history of adenotonsillectomy, lack of adenotonsillar hypertrophy) will be included. Investigators will conduct a randomized prospective comparative effectiveness study to assess the impact of treatment on OSA on endothelial function (peripheral arterial tonometry-EndoPAT). In addition to diagnostic polysomnography and EndoPAT at baseline, EV (extracellular vesicle) and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines concentrations, and body anthropometry will be measured. Following 3 mos of therapy and after 6mos of therapy, investigators will re-evaluate EndoPAT, EV and non EV derived miR 92a/miR 210 concentrations, inflammatory cytokines, and body anthropometry.
Throughout the study, investigators will maintain weekly telephone contact and monthly face-to-face visits as per standard of care in both groups to ensure ongoing success. In the medical management group (intensive diet and exercise), diet and exercise will be tracked by maintaining weekly telephone contact and monthly face-to-face visits with a registered dietician. For the CPAP group, investigators will also maintain weekly telephone contact and monthly face-to-face visits with a sleep technician to review mask fitting, and adherence reports, to optimize adherence to CPAP therapy.
Following completion at six months, polysomnography will be repeated.
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
- Single (Outcomes Assessor)
盲法说明
Investigators will randomize two groups of patients with OSA to receive either CPAP or intensive exercise. The study biostatistician will ensure that matching results in equal distributions of patients based on sex, age, race, severity of OSA, and obesity status.
入排标准
- 年龄范围
- 18 Years 至 21 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Otherwise healthy children and young adults with a diagnosis of obstructive sleep apnea based on polysomnography criteria of an obstructive apnea hypopnea index > 10 events/hr.
- •For children a BMI range up to 99.7% and for adults BMI up to 32 kg/m2 is used.
排除标准
- •The presence of elevated blood pressure
- •The presence of diabetes or pre-diabetes
- •The presence of craniofacial anomalies
- •The presence of neuromuscular disorders
- •The presence of syndromic or defined genetic abnormalities
- •Pregnancy
- •History of smoking (any smoking within the prior 6 mos or >5 pack years total)
- •The presence of infectious disease (e.g. including hepatitis B, C, HIV etc.)
- •The presence of collagen vascular disease (e.g. lupus, arthritis, scleroderma, polymyositis, mixed-connective tissue disease, vasculitis etc)
- •The presence of hepatic disease (including hepatitis fatty liver or cirrhosis)
- •The presence of renal disease (including azotemia or clinical proteinuria)
- •The presence of cardiopulmonary disease (e.g. known asthma, cystic fibrosis, congenital heart disease)
- •Individuals using medications which could affect sleep or breathing (including hypnotics)
- •Individuals using chronic anti-inflammatory therapy
- •Individuals with any subjects with acute or chronic illness.
- •Individuals using anti-hypertensive therapies
- •Children with a a BMI > 99.7%
- •Adults with a BMI > 32 kg/m2
研究组 & 干预措施
CPAP
This arm will consist of patients with obstructive sleep apnea who will be asked to use CPAP nightly to treat their OSA for six months
干预措施: Continuous Positive Airway Pressure (Device)
Diet and Exercise
This arm will consist of patients with obstructive sleep apnea who will be asked to engage in dietary management and regular exercise for six months.
干预措施: Diet And Exercise (Other)
结局指标
主要结局
Peripheral Arterial Tonometry - Reactive Hyperemic Index
时间窗: At six months.
EndoPAT
次要结局
- miR 92a and miR 210 levels(At six months.)
- miRNA 92a and miRNA 210 levels(At baseline.)
研究者
Rakesh Bhattacharjee
Associate Professor of Clinical Pediatrics
University of California, San Diego