Status:
COMPLETED
Cost-effectiveness Study of a Lifestyle Change Program for the Treatment of OSA and Obesity: Hospital-Primary Care.
Lead Sponsor:
Hospital Universitari de Bellvitge
Conditions:
Obstructive Sleep Apnea of Adult
Obesity
Eligibility:
All Genders
25-70 years
Phase:
NA
Brief Summary
Obesity is the main risk factor for Obstructive Sleep Apnea (OSA). Nasal CPAP is the standard treatment for OSA, but since weight-loss programs are not usually offered to OSA patients, the root causes...
Detailed Description
HYPOTHESIS The implementation of an intensive weight loss program, initiated under the supervision of an expert nutritionist and continued under the supervision of a trained primary care nurse can hel...
Eligibility Criteria
Inclusion
- diagnosed with severe OSA (apnea apnea hypopnea index (AHI)\> 30 / h),
- undergoing CPAP treatment for at least 6 months,
- with a body mass index (BMI)\> = 30 kg / m2 y = \<40 kg / m2,
- living in the area of the 5 participating primary care centers
Exclusion
- diseases that can limit the practice of exercise or adherence to diet,
- severe cognitive or psychiatric disorders that prevent understanding of the program,
- serious illnesses, severe cardiovascular disease with clinical instability during the month prior to inclusion,
- prior bariatric surgery,
- refusal of the patient to participate in the study and craniofacial malformations that prevent OSA improvement.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04296721
Start Date
January 1 2019
End Date
January 30 2021
Last Update
February 4 2021
Active Locations (1)
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1
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907