NCT02657304

Effect of Early Education on the Observance of CPAP Treatment

Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Sleep apnea (SA) affects more than 4% from general population and is largely underdiagnosed. SA can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment.

Detailed description

Sleep apnea (SA) affects more than 4% from general population (20% of people over 65 years) and is largely underdiagnosed, it can be rise up by some factors such as: obesity, male gender. Sleep Apnea can increase the occurrence of cardiovascular, endocrine and metabolic events (particularly stroke, diabetes \& obesity). CPAP is currently the Gold Standard treatment of SA and to prevent these events, with a major clinical benefit, long term adherence to CPAP is a significant problem where a significant rate of rejection and abundance after 6 months of treatment. The investigators hypothesize that an early education and information of SA (in the first 2 weeks after diagnosis of SA and one telephonic call/month while 5 months) would allow to increase significantly the optimal observance of CPAP (\> 5 h/night). Thus, in this study, we will compare evolution of the observance of CPAP (h/night), of the apnea hypopnea index (AHI), patient knowledge of their SA and its deleterious health consequences in an early education and information during five months against a control group receiving only usual care (standard).

Conditions

• Sleep Apnea Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Coaching group	patients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories.
OTHER	Control group	patients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months).

Timeline

• Start date: 2016-03-21
• Primary completion: 2021-01-01
• Completion: 2021-01-12
• First posted: 2016-01-15
• Last updated: 2021-08-06

Locations

1 site across 1 country: France