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NCT Number: NCT07152990

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

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Toulouse Hôpital Larrey

Toulouse, Occitanie, 31059, France

Location contact

Sandrine PONTIER

CONTACT

[email protected]

05 67 77 18 46

Sandrine PONTIER

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

  1. Prevalence of nocturnal alveolar hypoventilation

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine PONTIER

CONTACT

[email protected]

05 67 77 18 46

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Collaborators

  • Fonds de dotation Agir pour les Maladies Chroniques

Registry information

Official study title

Prevalence of Nocturnal Hypoventilation Diagnosed by Transcutaneous Oxy-capnography in a Population of Obese Subjects Fitted With Continuous Positive Airway Pressure for Obstructive Sleep Apnea Hypopnea Syndrome.

Acronym: CAPNOSOH

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 3, 2025
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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