Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea (HBO-POSA)
Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea: A Prospective Observational Cohort Study
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.
研究概览
地位
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Pierre TANKERE, Dr
- 电话号码:0472071929
- 邮箱:Pierre.tankere01@chu-lyon.fr
研究联系人备份
- 姓名:Laure PETER DEREX, Pr
- 电话号码:0472071929
- 邮箱:Laure.peter-derex@chu-lyon.fr
学习地点
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Lyon、法国、69004
- Croix-Rousse Hospital, Hospices Civils de Lyon
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接触:
- Pierre TANKERE, Dr
- 电话号码:0472071929
- 邮箱:Pierre.tankere01@chu-lyon.fr
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首席研究员:
- Virginie INFANTI, Dr
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的: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
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The only research-specific procedure is the completion of the Sleep Inertia Questionnaire (SIQ), a self-administered questionnaire requiring approximately 5 minutes to complete and performed once after the diagnostic sleep study.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Correlation between nocturnal hypercapnic burden and apnea-hypopnea index
大体时间:Baseline only (overnight diagnostic polysomnography)
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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. |
Baseline only (overnight diagnostic polysomnography)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 69HCL26_0743
- ID RCB (其他标识符:2026-A01760-51)
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