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.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Pierre TANKERE, Dr
- 電話番号：0472071929
- メール：Pierre.tankere01@chu-lyon.fr
研究連絡先のバックアップ
- 名前：Laure PETER DEREX, Pr
- 電話番号：0472071929
- メール：Laure.peter-derex@chu-lyon.fr
研究場所
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-
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Lyon、フランス、69004
- Croix-Rousse Hospital, Hospices Civils de Lyon
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コンタクト：
- Pierre TANKERE, Dr
- 電話番号：0472071929
- メール：Pierre.tankere01@chu-lyon.fr
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主任研究者：
- Virginie INFANTI, Dr
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：診断
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Correlation between nocturnal hypercapnic burden and apnea-hypopnea index
時間枠：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)
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 69HCL26_0743
- ID RCB (その他の識別子：2026-A01760-51)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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