Effect of Early Education on the Observance of CPAP Treatment (CoachSAS)

Centre Hospitalier Universitaire de Saint Etienne

Status: Completed

Conditions: Sleep Apnea Syndrome

Treatments: Other: Control group; Behavioral: Coaching group

Study type: Interventional

Funder types: Other

Identifiers

NCT02657304

1508146

2015-A01635-44 (Other Identifier)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Coaching group

Experimental group

Description:

PPC + Coaching

Treatment:

Behavioral: Coaching group

Control group

Active Comparator group

Description:

PPC

Treatment:

Other: Control group