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.
연구 개요
상태
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Pierre TANKERE, Dr
- 전화번호: 0472071929
- 이메일: Pierre.tankere01@chu-lyon.fr
연구 연락처 백업
- 이름: Laure PETER DEREX, Pr
- 전화번호: 0472071929
- 이메일: Laure.peter-derex@chu-lyon.fr
연구 장소
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Lyon, 프랑스, 69004
- Croix-Rousse Hospital, Hospices Civils de Lyon
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연락하다:
- Pierre TANKERE, Dr
- 전화번호: 0472071929
- 이메일: Pierre.tankere01@chu-lyon.fr
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수석 연구원:
- Virginie INFANTI, Dr
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
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디자인 세부사항
- 주 목적: 특수 증상
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Correlation between nocturnal hypercapnic burden and apnea-hypopnea index
기간: 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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연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
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QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 69HCL26_0743
- ID RCB (기타 식별자: 2026-A01760-51)
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