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Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea (CPAPcompl)

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ClinicalTrials.gov Identifier: NCT02301923
Recruitment Status : Unknown
Verified November 2014 by May Samaha, Saint-Joseph University.
Recruitment status was:  Not yet recruiting
First Posted : November 26, 2014
Last Update Posted : November 26, 2014
Sponsor:
Information provided by (Responsible Party):
May Samaha, Saint-Joseph University

Study Description
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Brief Summary:
This study aims to determine the average compliance of a patient under CPAP therapy for obstructive sleep apnea as well as the various factors that influence it.

Condition or disease
Sleep Apnea, Obstructive Patient Compliance

Detailed Description:

Obstructive Sleep Apnea (OSA) is a frequent disease that affects 4% of the male population and 2% of the female population, with well known repercussions on the quality of life (daytime drowsiness, concentration issues, increased motor vehicle accidents, etc) and cardiovascular risk (increased risk of strokes, hypertension, diabetes, CAD, etc.). It is caused by an intermittent relaxation of the throat muscles during sleep, thus blocking the airways and leading to snoring and apnea.

Treatment can involve diets and sports, sleep hygiene techniques, mandibular advancement devices. But the CPAP (continuous positive airway pressure) device remains the first line therapy for OSA. It is very effective at reducing apnea-hypopnea (AHI) and oxygen desaturation indexes (ODI), but poor compliance is often noticed, with only 46% of patients still using the device at 6 months.

Despite numerous studies on the subject, very few have included a large number of patients(>150) or long follow up time (>1 year), or reached conclusive evidence concerning the factors that influence CPAP compliance.

In order to determine these factors, the investigators have taken into account approximately 450 patients over a timeframe of 5 years who have used a CPAP device during the course of their disorder, and established a Kaplan-Meyer estimation of their survival function. The investigators have then used anthropometry (BMI, neck circumference, sex, age, etc.), polysomnography (Epworth score, AHI, ODI, sleep efficiency, etc.) and CPAP (pressures, leaks, etc.) data with a Cox regression in order to determine the factors that influence the compliance of a patient.

The results will allow us to establish the average compliance of a patient under CPAP therapy, as well as the reasons leading to its termination, the factors predicting a decreased compliance and the consequences of stopping the treatment. This will allow us to set up multiple methods of improved follow-up in patients that are predicted recalcitrant to CPAP therapy.

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Predictive Factors Determining Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
Study Start Date : November 2014
Actual Primary Completion Date : November 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
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Group/Cohort
CPAP compliant (C)
Patients confirmed with obstructive sleep apnea and succeeded to pursue treatment with CPAP
CPAP noncompliant (NC)
Patients confirmed with obstructive sleep apnea but did not succeed to pursue treatment with CPAP


Outcome Measures
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Primary Outcome Measures :
  1. Compliance time to CPAP [ Time Frame: 6 years ]
    Survival study taking the noncompliance to CPAP treatment as an event


Secondary Outcome Measures :
  1. Predictive factors related to the patient for compliance to CPAP (Sociologic and economic status, medical co morbidities, Anthropometric characteristics) [ Time Frame: 6 years ]
    Factors related to the patient: Sociologic and economic status, medical co morbidities, Anthropometric characteristics.

  2. Predictive factors related to the provider for compliance to CPAP (Attitude of the provider (active, passive), consistency/quality of the follow up) [ Time Frame: 6 years ]
    Factors related to the provider: Attitude of the provider (active, passive), consistency/quality of the follow up.

  3. Predictive factors related to the device for compliance to CPAP (Mask type, use of a humidification, Device type/mode, Pressure set, Cost, Side effects) [ Time Frame: 6 years ]
    Factors related to the device: Mask type, use of a humidification, Device type/mode, Pressure set, Cost, Side effects.

  4. Predictive factors related to OSA for compliance to CPAP (Severity score, fatigue and Epworth score, Polysomnography profile (AHI, ODI, Arousal index…), use of alternative treatments) [ Time Frame: 6 years ]
    Factors related to OSA: Severity score, fatigue and Epworth score, Polysomnography profile (AHI, ODI, Arousal index…), use of alternative treatments.

  5. Cardiovascular outcome/benefits (cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias) [ Time Frame: 6 years ]
    cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias; timeframe: after CPAP cessation


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients diagnosed with OSA in the sleep center of Hotel Dieu de France (HDF) hospital, treated for at least one day by CPAP, from the period of June 2008 to June 2013.
Criteria

Inclusion Criteria:

  • All HDF patients with OSA, treated for at least one day by CPAP, from the period of June 2008 to June 2013.

Exclusion Criteria:

  • None
Contacts and Locations
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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): NCT02301923


Contacts
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Contact: Moussa A Riachy, Ass Prof 9613361672 riachy@dm.net.lb
Contact: Mirella Skandar, M.D. 9617231331 mirella.iskandar@gmail.com

Locations
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Lebanon
Hotel Dieu de France Hospital
Beirut, Lebanon
Contact: Moussa A Riachy, MD, FCCP    961 1 615300 ext 9218    riachy@dm.net.lb   
Contact: Mirella Skandar, MD    96170231331    mirella.iskandar@gmail.com   
Sub-Investigator: Jad Choucair, MD         
Sub-Investigator: Samer Najem, MD         
Sponsors and Collaborators
Saint-Joseph University
Investigators
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Principal Investigator: Moussa Riachy, Ass Prof Saint Joseph Univ
More Information
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Additional Information:

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Responsible Party: May Samaha, Moussa Riachy MD FCCP, Saint-Joseph University
ClinicalTrials.gov Identifier: NCT02301923    
Other Study ID Numbers: HDF575
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: November 26, 2014
Last Verified: November 2014
Keywords provided by May Samaha, Saint-Joseph University:
Continuous Positive Airway Pressure
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
 Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases