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

• ClinicalTrials.gov Identifier: NCT02301923
• Recruitment Status: Unknown
• First Posted: November 26, 2014
• Last Update Posted: November 26, 2014
• Sponsor: Saint-Joseph University
• Information provided by (Responsible Party): May Samaha, Saint-Joseph University

Tracking Information

• First Submitted Date: November 2, 2014
• First Posted Date: November 26, 2014
• Last Update Posted Date: November 26, 2014
• Study Start Date: November 2014
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 25, 2014)

Compliance time to CPAP [ Time Frame: 6 years ]

Survival study taking the noncompliance to CPAP treatment as an event

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 25, 2014)

• 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.
• 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.
• 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.
• 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.
• 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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
• Official Title: Predictive Factors Determining Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
• 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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Retrospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.

Condition

• Sleep Apnea, Obstructive
• Patient Compliance

• Intervention: Not Provided

Study Groups/Cohorts

• 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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: November 25, 2014): 450
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 2015
• Actual Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Lebanon

Administrative Information

• NCT Number: NCT02301923
• Other Study ID Numbers: HDF575
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: May Samaha, Saint-Joseph University
• Original Responsible Party: Same as current
• Current Study Sponsor: Saint-Joseph University
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Moussa Riachy, Ass Prof; Saint Joseph Univ

• PRS Account: Saint-Joseph University
• Verification Date: November 2014