Effect of Early Education on the Observance of CPAP Treatment (CoachSAS)
Primary Purpose
Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Coaching group
Control group
Sponsored by
About this trial
This is an interventional other trial for Sleep Apnea Syndrome focused on measuring Sleep Apnea, CPAP
Eligibility Criteria
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
Sites / Locations
- Chu Saint-Etienne
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Coaching group
Control group
Arm Description
PPC + Coaching
PPC
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02657304
First Posted
January 13, 2016
Last Updated
August 5, 2021
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
1. Study Identification
Unique Protocol Identification Number
NCT02657304
Brief Title
Effect of Early Education on the Observance of CPAP Treatment
Acronym
CoachSAS
Official Title
Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 21, 2016 (Actual)
Primary Completion Date
January 2021 (Actual)
Study Completion Date
January 12, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea Syndrome
Keywords
Sleep Apnea, CPAP
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Coaching group
Arm Type
Experimental
Arm Description
PPC + Coaching
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
PPC
Intervention Type
Behavioral
Intervention Name(s)
Coaching group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control group
Intervention Description
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).
Primary Outcome Measure Information:
Title
Observance
Description
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
Time Frame
5 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frédéric ROCHE, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
St Etienne
ZIP/Postal Code
42055
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Early Education on the Observance of CPAP Treatment
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