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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-A00694-45 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Fonds de dotation Agir pour les Maladies Chroniques | UNKNOWN |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obese Patients with Obstructive Sleep Apnea/Hypopnea | Other |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of nocturnal alveolar hypoventilation | 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. | 1 month |
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Inclusion criteria:
Exclusion criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sandrine PONTIER | Contact | 05 67 77 18 46 | pontier.s@chu-toulouse.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Toulouse Hôpital Larrey | Toulouse | Occitanie | 31059 | France |
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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.
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| Quality of life questionnaires | Other | Epworth Sleepiness Scale, Pittsburgh Sleep Quality Index, and the "Patient-Reported Hypoventilation Questionnaire". |
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| Arterial gasometry | Other | Arterial blood gas analysis will be performed only in patients presenting nocturnal hypoventilation. |
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| 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. |
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| 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. |
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| 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. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D020181 | Sleep Apnea, Obstructive |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D012149 | Restraint, Physical |
| ID | Term |
|---|---|
| D032763 | Behavior Control |
| D013812 | Therapeutics |
| D007103 | Immobilization |
| D008919 | Investigative Techniques |
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