Effect of Early Education on the Observance of CPAP Treatment
CoachSAS
Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment
2 other identifiers
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2016
CompletedFirst Posted
Study publicly available on registry
January 15, 2016
CompletedStudy Start
First participant enrolled
March 21, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 12, 2021
CompletedAugust 6, 2021
August 1, 2021
4.8 years
January 13, 2016
August 5, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Coaching group
EXPERIMENTALPPC + Coaching
Control group
ACTIVE COMPARATORPPC
Interventions
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.
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).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known diseases which contraindicated used of CPAP treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chu Saint-Etienne
Saint-Etienne, 42055, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric ROCHE, MD
CHU SAINT-ETIENNE
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 13, 2016
First Posted
January 15, 2016
Study Start
March 21, 2016
Primary Completion
January 1, 2021
Study Completion
January 12, 2021
Last Updated
August 6, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share