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Hypercapnic burden in adults with obesity undergoing diagnostic polysomnography for suspected obstructive sleep apnea: a prospective observational cohort study

NCT ID NCT07809061

NEW Sponsor: Hospices Civils de Lyon Source: ClinicalTrials.gov ↗

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Cancelled before anyone took part.

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Approved
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When the status isn't known

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder obesity-hypoventilation syndrome obstructive sleep apnea syndrome sleep apnea syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Obesity (bmi>30) Obesity hypoventilation syndrome (OHS) Obstructive sleep apnea Sleep hypoventilation

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Croix-Rousse Hospital, Hospices Civils de Lyon

    Lyon, 69004, France

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