Effect of Early Education on the Observance of CPAP Treatment

Not Applicable

Completed

• Conditions: Sleep Apnea Syndrome
• Interventions: Other: Control group; Behavioral: Coaching group

• Registration Number: NCT02657304
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief 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).

Study Timeline

• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-13
• Study First Posted: 2016-01-15
• Study Start: 2016-03-21
• Primary Completion: 2021-01
• Study Completion: 2021-01-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Patients affiliated or entitled to a French medical insurance
• Patients of both gender, aged from 18 to 80 years
• Patients with AHI > 30/hour or between 15 & 30/h with Sleep Fragmentation Index (SFI) of more than 10/h
• Signature of consent

Exclusion Criteria

• Known diseases which contraindicated used of CPAP treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Control group	PPC
Coaching group	Coaching group	PPC + Coaching

Primary Outcome Measures

Name	Time	Method
Observance	5 months	Percentage of patients with a mean duration of observance of more than 5h/night after five months of follow-up in the coached and the control groups

Trial Locations

Locations (1)

Chu Saint-Etienne; 🇫🇷 St Etienne, France