Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea: A Prospective Observational Cohort Study
| Registry | NCT07809061, acronym HBO-POSA |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, diagnostic |
| Enrollment | 150 (Estimated) |
| Sponsor | Hospices Civils de Lyon (Other) |
| Conditions | Obstructive Sleep Apnea, Obesity (BMI>30), Obesity Hypoventilation Syndrome (OHS), Sleep Hypoventilation |
| Interventions | Sleep Inertia Questionnaire (SIQ) (Behavioral) |
| Dates | start 2026-11-01 (estimated), primary completion 2028-11-03 (estimated), completion 2028-11-03 (estimated), first posted 2026-09-09, last updated 2026-09-09 |
| Locations | 1 site in France |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Adults with obesity referred for diagnostic polysomnography | Experimental | Behavioral: Sleep Inertia Questionnaire (SIQ) | 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 |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Croix-Rousse Hospital, Hospices Civils de Lyon | Lyon | France |