Effect of Early Education on the Observance of CPAP Treatment

Sleep Apnea Syndrome Clinical Trial

— CoachSAS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02657304
• Other study ID #: 1508146
• Secondary ID: 2015-A01635-44
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: January 12, 2021

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 12, 2021
• Est. primary completion date: January 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea Syndrome
• Sleep Apnea Syndromes

Intervention

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.

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).

Locations

Country	Name	City	State
France	Chu Saint-Etienne	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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