Effect of Early Education on the Observance of CPAP Treatment (CoachSAS)
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|ClinicalTrials.gov Identifier: NCT02657304|
Recruitment Status : Recruiting
First Posted : January 15, 2016
Last Update Posted : January 29, 2019
|Condition or disease||Intervention/treatment||Phase|
|Sleep Apnea Syndrome||Behavioral: Coaching group Other: Control group||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effect of Early Education and Information of Sleep Apnea on the Observance of CPAP Treatment|
|Actual Study Start Date :||March 21, 2016|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||February 2021|
Experimental: Coaching group
PPC + Coaching
Behavioral: Coaching group
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.
Active Comparator: Control group
Other: Control group
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).
- Observance [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657304
|Contact: Frédéric ROCHE, MDemail@example.com|
|Contact: Ahmad NSAIR, MDfirstname.lastname@example.org|
|St Etienne, France, 42055|
|Contact: Frédéric ROCHE, PhD +33477828300 email@example.com|
|Principal Investigator: Frédéric ROCHE, PhD|
|Sub-Investigator: Jean-Claude BARTHELEMY, PhD|
|Sub-Investigator: Isabelle COURT-FORTUNE, MD|
|Principal Investigator:||Frédéric ROCHE, MD||CHU SAINT-ETIENNE|