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Completed

NCT Number: NCT01903135

Prevalence of Obesity Hypoventilation Syndrome

Rationale of the "BIO-OHS" study (Prevalence of Obesity Hypoventilation Syndrome):

The overall prevalence of Obesity Hypoventilation Syndrome (OHS) has never been directly assessed in the general population. Actually, this prevalence has been assessed in patients referred to sleep clinics with a potential diagnosis of sleep-disordered breathing or in patients already diagnosed with sleep apnea. The purpose of this study is to determine the prevalence of Obesity Hypoventilation syndrome in obese patients referred to clinical laboratories for regular follow-up medical analysis.

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Key information

Conditions

Obesity Hypoventilation Syndrome Apnea Dyssomnias Hypoventilation Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Michallon, Laboratoire EFCR et Sommeil, Grenoble, France

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About this study

No additional description

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 18 years old ans more
  • BMI over 30 kg/M2
  • Stable state (respiratory, metabolic and cardio-vascular) for the last 2 months
  • Addressed to a clinical labs for a blood check-up whatever the prescription

Exclusion criteria

  • No social security
  • Non cooperative patient, as judged by the investigator

Treatment and study plan

Blood test analysis in the clinical labs

Procedure

for specific measurement of plasmatic bicarbonate

Pneumologist consult to establish the diagnosis of OHS

Procedure

complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.

Medical history, previous treatments.

Primary outcomes

  1. Prevalence of Obesity Hypoventilation Syndrome (OHS) in obese subjects referred to clinical laboratories for regular blood test analysis.

    Time frame: From date of inclusion until the end of the study currently planned (up to 2 years)

    OHS prevalence, validated by arterial blood gases analysis, will be assessed by the percentage of patients with OHS among all patients included in the study

Secondary outcomes

  1. Sensitivity and specificity of plasmatic [HCO3-] to detect OHS

    Time frame: From date of inclusion to the end of the study currently planned (2 years)

    A ROC curve will determine if the threshold of 27 mmol/L has the best diagnostic value.

    Decision trees will show if the diagnostic value of plasmatic [HCO3-]could be optimized by a combination with other clinical parameters.

  2. Prevalence of metabolic and cardiovascular comorbidities in patients with OHS

    Time frame: From date of inclusion to the end of the study currently planned (2 years)

    Prevalence will be estimated by the percentage and the confidence interval. Prevalences of metabolic and cardiovascular comorbidities among patients with OHS and without OHS will be compared by a KHI-2 test or Fisher Exact depends on the theorical number.

  3. To determine which medical specialties referred patients with OHS to clinical labs

    Time frame: From date of inclusion to the end of the study currently planned (2 years)

    estimated by percentage

  4. Incidence of serious health events at 1 and 2-year follow-up

    Time frame: From time of OHS diagnostic to 1 and 2-year follow-up

    Cardiovascular, metabolic and respiratory events (measured by percentages in OHS group and non-OHS group) will be compared by logistic regressions.

Sponsors and collaborators

Lead sponsor

AGIR à Dom

Other

Registry information

Official study title

Prevalence of Obesity Hypoventilation Syndrome in Subjects With Obesity Referred to Clinical (Medical Analysis) Laboratories for Regular Follow-up

Acronym: BIO-OHS

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Jul 19, 2013
Registry last updated
Feb 1, 2017

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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