Effect of Early Education on the Observance of CPAP Treatment

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Sleep Apnea Syndrome

Intervention / Treatment
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* Behavioral: Coaching group
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coaching group<br>PPC + Coaching | Behavioral: Coaching group<br>* 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.<br>|
| Active Comparator: Control group<br>PPC | Other: Control group<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Observance | 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 | 5 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CPAP, Sleep Apnea