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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-05-31

Brief Summary

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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).

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Detailed Description

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Obstructive sleep apnea hypopnea syndrome (OSAS) is highly prevalent in the global population (1 in 10 people worldwide according to Inserm), particularly in relation to the increase in the prevalence of obesity. The standard treatment for this pathology is continuous positive airway pressure (CPAP) which most often allows, when properly applied and adjusted, the normalization of symptoms and the apnea-hypopnea index (AHI). In addition to OSAHS, some obese subjects are at risk of presenting hypoventilation obesity syndrome (OHS) defined by the presence of obesity (body mass index \[BMI\] \> 30 kg/m2) associated with diurnal hypoventilation. (PaCO2 \> 45 mmHg) in the absence of other respiratory pathology. Identifying patients with OS is often difficult but essential, as early as possible.

Transcutaneous capnography, when properly performed and interpreted, is a much more informative tool than nocturnal oximetry, and could therefore allow better screening for these patients. It is an examination increasingly used in pulmonology departments/sleep centers.

The 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). The study hypothesis is based on the limited data present in the literature. This is preliminary work for a multicenter study aimed at determining the impact of nocturnal hypoventilation without daytime hypercapnia on the quality of life and morbidity and mortality of patients.

We estimate that between 10 to 20% of obese subjects on CPAP hypoventilate at night.

Conditions

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Nocturnal Hypoventilation Obesity Sleep Apnea Hypopnea Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

All patients will undergo transcutaneous oxy-capnography and answer quality of life questionnaires. Only patients presenting nocturnal hypoventilation defined with PTcCO2 \> 49 mmHg more than 10% of the time of capnographic recording will continue the study with additional interventions. Patients without nocturnal hypoventilation will finish the study after the capnographic recording visit.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Obese Patients with Obstructive Sleep Apnea/Hypopnea

Group Type OTHER

Transcutaneous Oxy-Capnography

Intervention Type 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

Intervention Type OTHER

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

Arterial gasometry

Intervention Type OTHER

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

Body plethysmography

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Quality of life questionnaires

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

Intervention Type OTHER

Arterial gasometry

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

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

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.

Intervention Type OTHER

Eligibility Criteria

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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