Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Obesity Hypoventilation Syndrome
  • Obstructive Sleep Apnea
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Open, controlled, randomized clinical trial (cluster randomization)Masking: None (Open Label)Primary Purpose: Screening

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

Description

OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortal...

OSA is a frequent condition in the general population (3% of women and 10% of men), but remains largely undiagnosed. Obesity is a risk factor for OSA. Sleep apnea is associated with diurnal and nocturnal symptoms (snoring, somnolence, fatigue), and with increased cardiometabolic morbidity and mortality. Currently, continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA and the cost-effectiveness of this treatment has already been demonstrated. Easy-to-use procedures to identify OSA patients earlier and thus to initiate treatment earlier, need to be developed and validated. The STOP-BANG questionnaire has been designed to facilitate the screening of OSA patients. Moreover, a measure of blood bicarbonate concentration is a simple method for screening for chronic respiratory diseases and a marker of cardiometabolic comorbidities. A combination of blood bicarbonate measurement and STOP-BANG score could permit earlier screening and less expensive care of obese patients. The hypothesize is that such OSA screening in the obese population (bicarbonates + STOPBANG) associated with earlier care (with treatment if necessary) could lead to improvement in quality of life of obese patients at 2 years.

Tracking Information

NCT #
NCT03861468
Collaborators
  • University Hospital, Angers
  • Poitiers University Hospital
  • Union hospital, Toulouse
  • Hospital Alpes Leman, Annemasse
  • Hospital La Louvière, Lille
  • Oriade Laboratory, Vizille
  • Cerballiance laboratories, Lille
  • Oriade laboratory, Annemasse
Investigators
Principal Investigator: Jean-Louis PEPIN, MD, PhD Grenoble Alpes University Hospital