Hypercapnic Burden in Adults With Obesity Undergoing Diagnostic Polysomnography for Suspected Obstructive Sleep Apnea

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Sleep Inertia Questionnaire (SIQ)

    Behavioral

    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.

Treatment groups

150 Participants
are divided into 1 treatment group
Group A: Adults with obesity referred for diagnostic polysomnographyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between nocturnal hypercapnic burden and apnea-hypopnea index

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.

Time frame
Baseline only (overnight diagnostic polysomnography)

Secondary outcomes

Other outcomes

Sponsors and contacts

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