Medico-economics and QoL of Obese Patients Followed by Medical Analysis Laboratories (BIOSAOS )
Last updated on July 2021Recruitment
- 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