Obesity (BMI>30), Obesity Hypoventilation Syndrome (OHS), Obstructive Sleep Apnea, Sleep Hypoventilation
Conditions
Keywords
Hypercapnic burden, Transcutaneous carbon dioxide, Polysomnography, Obesity, Sleep apnea, Sleep hypoventilation
Brief summary
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.
Interventions
BEHAVIORALSleep Inertia Questionnaire (SIQ)
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.
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single-centre, prospective, RIPH 3 - research involving human subjects outside of health products
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between nocturnal hypercapnic burden and apnea-hypopnea index | 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. |
Countries
France
Contacts
CONTACTPierre TANKERE, Dr
CONTACTLaure PETER DEREX, Pr
Outcome results
None listed