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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
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.

Condition or disease Intervention/treatment Phase
Sleep Apnea Syndrome Behavioral: Coaching group Other: Control group Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arm Intervention/treatment
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
PPC
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).




Primary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Frédéric ROCHE, MD +33477828300 frederic.roche@univ-st-etienne.fr
Contact: Ahmad NSAIR, MD nsair_ahmad@hotmail.fr

Locations
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France
Chu Saint-Etienne Recruiting
St Etienne, France, 42055
Contact: Frédéric ROCHE, PhD    +33477828300    frederic.roche@univ-st-etienne.fr   
Principal Investigator: Frédéric ROCHE, PhD         
Sub-Investigator: Jean-Claude BARTHELEMY, PhD         
Sub-Investigator: Isabelle COURT-FORTUNE, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Frédéric ROCHE, MD CHU SAINT-ETIENNE

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02657304     History of Changes
Other Study ID Numbers: 1508146
2015-A01635-44 ( Other Identifier: ANSM )
First Posted: January 15, 2016    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Sleep Apnea
CPAP

Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases