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临床试验/NCT04793334
NCT04793334Enrolling By Invitation不适用

Underlying Mechanisms of Obesity-induced Obstructive Sleep Apnea

Brandon Nokes1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
110
试验地点
1
主要终点
changes in pcrit after bariatric surgery

研究概览

简要总结

Obesity is a common risk factor for the development of obstructive sleep apnea. However, not all subjects with obesity develop obstructive sleep apnea. This study will attempt to determine the mechanistic drivers between obesity and obstructive sleep apnea.

详细描述

Obstructive sleep apnea (OSA) is a highly prevalent disease with major neurocognitive and cardiovascular sequelae. Obesity is a major risk factor for OSA, but the underlying mechanisms remain unclear. Given the rising prevalence of obesity and the lack of adequate therapies for some afflicted patients, further mechanistic work is clearly required. Bariatric surgery is being done increasingly with compelling outcome data emerging; however, clinical response to weight loss is highly variable. In some patients, OSA is not present at baseline, despite morbid obesity, in other patients, OSA resolves following bariatric surgery, while other patients have persistence of OSA despite weight loss, and still other patients can experience re-emergence of OSA in long term follow-up studies after bariatric surgery. OSA can occur due to several major pathophysiological factors including pharyngeal anatomy, pharyngeal dilator muscle dysfunction, unstable ventilatory control, end- expiratory lung volume and arousal threshold. As a result considerable complexity exists in the obesity/OSA relationship, suggesting the need for further research. First, the investigators will perform a baseline evaluation of pathophysiological traits among obese people prior to weight loss surgery. Because some people will have OSA and some will not, the investigators will define the potential mechanisms underlying OSA and potential protective mechanisms among obese people without OSA (pharyngeal critical closing pressure Pcrit primary outcome). Second, the investigators will re-evaluate these same individuals from the standpoint of sleep study and pathophysiological traits six months following bariatric surgery after a variable degree of weight loss. The investigators anticipate that some OSA patients will have resolution of OSA whereas others will have persistence of disease. For non-OSA patients undergoing weight loss, the investigators will have a positive control group which will allow the investigators to account for non-specific effects of weight loss. This aim will allow the investigators to test the hypothesis that pharyngeal mechanics is the predominant mechanism whereby weight loss leads to improvement in OSA. Third, the investigators will perform magnetic resonance imaging during wakefulness at functional residual capacity, total lung capacity and residual volume on participants at baseline and 6months following bariatric surgery. This aim will allow the investigators to perform structure/function assessments in our participants, to define the impact of weight loss on pharyngeal anatomy, and to quantify the lung volume dependence of the upper airway before and after weight loss. The acquired data will also be used for computational modeling including dynamic assessment of pharyngeal function during tidal breathing. As a result of the proposed research, the investigators are confident that the investigators will gain major insights into the as yet unanswered question "why does obesity (sometimes) cause sleep apnea". This research will have major therapeutic implications as it will allow the investigators to individualize therapy for afflicted patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • - Men and women
  • Ages >= 18-65 years old
  • BMI 35 kg/m2--and above
  • Scheduled for sleeve gastrectomy (bariatric surgery)

排除标准

  • Any cardiovascular, pulmonary or renal disease other than well-controlled hypertension or asthma.
  • Pregnancy
  • Currently smoking
  • Any respiratory disorder other than OSA or well controlled asthma
  • contraindication to MRI

结局指标

主要结局

changes in pcrit after bariatric surgery

时间窗: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

2. We will reassess obese people with and without OSA following major weight loss (bariatric surgery). This aim will allow us to test the hypothesis that patients who experience improvement in OSA will be those with the greatest improvement in upper airway mechanics (Pcrit). The obese people without OSA undergoing weight loss will be a positive control group, which will allow us to exclude non-specific effects of weight loss.

muscle traits contributing to OSA in obesity - change is being assessed over time

时间窗: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

1. To measure upper airway collapsibility as well as the other traits (e.g. muscle responsiveness) in both groups. The traits can be measured during sleep using our well-validated research method that mimics transient upper airway obstruction and importantly, assesses the individual's response to hypoventilation

MRI upper airway changes following bariatric surgery - change is being assessed over time

时间窗: Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery

3. To determine the anatomic correlates of upper airway collapsibility in both groups using magnetic resonance imaging during natural sleep.

次要结局

  • exploratory outcomes(Time point 1: Within 1 month of bariatric surgery, Time point 2: 6 months following bariatric surgery)

研究者

发起方
Brandon Nokes
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Brandon Nokes

Post-doctoral fellow, Division of Pulmonary, Critical Care, Sleep Medicine, and Physiology

University of California, San Diego

研究点 (1)

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