Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea: A Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation between nocturnal hypercapnic burden and apnea-hypopnea index
研究概览
简要总结
Obesity-related sleep hypoventilation represents a continuum ranging from isolated nocturnal hypoventilation to obesity hypoventilation syndrome. Current diagnostic criteria rely mainly on dichotomous thresholds and may not adequately reflect cumulative nocturnal carbon dioxide exposure.
Hypercapnic burden, defined as the cumulative area under the transcutaneous carbon dioxide (PtcCO₂) curve above a predefined threshold, has recently emerged as a novel physiological marker integrating both the intensity and duration of nocturnal hypercapnia.
This prospective observational cohort study aims to evaluate the association between nocturnal hypercapnic burden and obstructive sleep apnea severity, assessed by the apnea-hypopnea index (AHI), in adults with obesity referred for diagnostic polysomnography.
Secondary objectives include evaluating associations between hypercapnic burden and sleep architecture, respiratory events, oxygenation parameters, daytime symptoms, and patient-reported outcomes. In addition, the study will investigate the relationship between nocturnal hypercapnic burden and sleep inertia, assessed using the Sleep Inertia Questionnaire (SIQ), based on the hypothesis that greater nocturnal carbon dioxide exposure immediately before awakening may contribute to impaired alertness upon awakening.
Hypothesis: Increased nocturnal hypercapnic burden is associated with greater obstructive sleep apnea severity and reflects an additional physiological dimension of obesity-related sleep hypoventilation beyond conventional polysomnographic indices. Furthermore, higher nocturnal hypercapnic burden is hypothesized to be associated with greater sleep inertia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥18 years.
- •Body mass index (BMI) ≥30 kg/m².
- •Referred to the Sleep Medicine Center for routine diagnostic polysomnography because of suspected obstructive sleep apnea.
- •Affiliated with a French health insurance scheme.
- •Received information about the study and did not object to the use of their data.
- •Able to understand the study information and complete study questionnaires.
排除标准
- •Legal incapacity or inability to provide non-opposition to participation.
- •Previous treatment with continuous positive airway pressure (CPAP) or non-invasive ventilation.
- •Participation in another interventional clinical study that could interfere with the present study.
研究组 & 干预措施
Adults with obesity referred for diagnostic polysomnography
Adults with obesity (body mass index ≥30 kg/m²) referred to the Sleep Medicine Center for routine diagnostic polysomnography because of suspected obstructive sleep apnea
干预措施: Sleep Inertia Questionnaire (SIQ) (Behavioral)
结局指标
主要结局
Correlation between nocturnal hypercapnic burden and apnea-hypopnea index
时间窗: Baseline only (overnight diagnostic polysomnography)
Correlation between nocturnal hypercapnic burden above 45 mmHg (HB45), defined as the area under the nocturnal transcutaneous carbon dioxide pressure (PtcCO₂) curve above 45 mmHg and normalized per hour of recording (mmHg·min/hour), and the apnea-hypopnea index derived from diagnostic polysomnography (events/hour). The correlation will be assessed using Pearson's or Spearman's correlation coefficient, according to data distribution.
次要结局
未报告次要终点