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OpenTrials
Completed

NCT Number: NCT02657304

Effect of Early Education on the Observance of CPAP Treatment

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Saint-Etienne

Saint-Etienne, 42055, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coaching Group

Behavioral

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.

Control Group

Other

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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Acronym: CoachSAS

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Jan 15, 2016
Registry last updated
Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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