Clinical trial

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

Opening soon · Not applicable · 1 countries · Registry ID NCT07152990

Opening soonNot applicableInterventional

What this study is about

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).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionNocturnal Hypoventilation, Obesity, Sleep Apnea Hypopnea Syndrome

Full registry criteria

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)

Treatments and study arms

Transcutaneous Oxy-Capnography

Other

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

Other

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

Arterial gasometry

Other

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

Body plethysmography

Other

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

Other

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

Other

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.

Primary outcomes

Prevalence of nocturnal alveolar hypoventilation1 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.

Study locations

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CHU de Toulouse Hôpital Larrey🇫🇷 Toulouse, Occitanie, France

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Sandrine PONTIERContact

Email · Call 05 67 77 18 46

Sandrine PONTIERPrincipal Investigator