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Starting soon Not applicable

Prevalence of Nocturnal Hypoventilation in Obese Subjects Fiited With Continuous Positive Airway Pressure for Obstructive Sleep Apnea / Hypopnea Syndrome

NCT07152990 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-09
Last updated
2025-09-03

Condition(s) studied

Nocturnal HypoventilationObesitySleep Apnea Hypopnea Syndrome

Investigational drug(s) / intervention(s)

Transcutaneous Oxy-CapnographyQuality of life questionnairesArterial gasometryBody plethysmographySpirometry with reversibility testClinical examination

Transcutaneous Oxy-Capnography: Patients will be monitored using transcutaneous oxy-capnography to evaluate the prevalence of nocturnal alveolar hypoventilation in these population. Nocturnal alveolar hypoventilation is defined with PTcCO2 \> 49 mmHg more than 10% of the time of capnographic recording.

Quality of life questionnaires: Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and the "Patient-Reported Hypoventilation Questionnaire".

Arterial gasometry: Arterial blood gas analysis will be performed only in patients presenting nocturnal hypoventilation.

Body plethysmography: Plethysmography will be performed only in patients presenting nocturnal hypoventilation. It will be used to measure lung volume and assess pulmonary function. This non-invasive procedure involves the patient breathing into a device that measures changes in pressure within a sealed chamber.

Spirometry with reversibility test: The intervention will be performed only in patients presenting nocturnal hypoventilation. Spirometry with a reversibility test will be performed to assess lung function and evaluate the response to bronchodilators. The procedure involves measuring forced expiratory volume and forced vital capacity before and after the administration of a bronchodilator.

Clinical examination: Clinical exam will be performed only in patients presenting nocturnal hypoventilation. It will consists of standard interview/clinical examination: vital signs, cardiological, pulmonary, abdominal, neurological examination, search for clinical signs of nocturnal hypoventilation, search for signs of hypoxia/hypercapnia, pulmonary auscultation.

Study summary

CAPNOSOH study is a single-center study conducted at Toulouse University Hospital, aiming to estimate the prevalence of obese and apneic subjects maintaining nocturnal hypoventilation under continuous positive airway pressure (CPAP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion criteria: * Obese patients (Body Mass Index \> 30 kg/m2) * Fitted by one of the following providers: ASTEN, Vitalaire, Orkyn, ISIS, RespiO2, BASTIDE for \> 3 months with compliance of more than 4 consecutive hours per night in average during 3 months * "Good quality" criteria for continuous positive airway pressure (CPAP) treatment: compliance \> 4 consecutive hours per night, unintentional leaks \< limit defined by the manufacturer, residual AHI \< 10/h * Aged 18 to 80 * Affiliated or beneficiaries of the social security system or equivalent * Having given written informed consent * Able to understand instructions and information given Exclusion criteria : * Patient under legal protection measure * Non-compliant patients * Pregnant or breast-feeding women (assessed on questioning)

Primary outcome measure(s)

  • Prevalence of nocturnal alveolar hypoventilation — 1 month
    Prevalence of nocturnal alveolar hypoventilation will be diagnosed by transcutaneous oxy-capnography. Nocturnal alveolar hypoventilation is defined with PTcCO2 \> 49 mmHg more than 10% of the time of capnographic recording.

Trial sites (1)

FacilityCityRegionStatus
CHU de Toulouse Hôpital Larrey Toulouse Occitanie
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07152990 on ClinicalTrials.gov ↗ ← All trials in France