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

NCT ID: NCT02301923

Last Updated: 2014-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-30

Study Completion Date

2015-03-31

Brief Summary

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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

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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.

Conditions

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Sleep Apnea, Obstructive Patient Compliance

Keywords

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Continuous Positive Airway Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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CPAP compliant (C)

Patients confirmed with obstructive sleep apnea and succeeded to pursue treatment with CPAP

No interventions assigned to this group

CPAP noncompliant (NC)

Patients confirmed with obstructive sleep apnea but did not succeed to pursue treatment with CPAP

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saint-Joseph University

OTHER

Sponsor Role lead

Responsible Party

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May Samaha

Moussa Riachy MD FCCP

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Moussa Riachy, Ass Prof

Role: PRINCIPAL_INVESTIGATOR

Saint Joseph Univ

Locations

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Hotel Dieu de France Hospital

Beirut, , Lebanon

Site Status

Countries

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Lebanon

Central Contacts

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Moussa A Riachy, Ass Prof

Role: CONTACT

Phone: 9613361672

Email: [email protected]

Mirella Skandar, M.D.

Role: CONTACT

Phone: 9617231331

Email: [email protected]

Facility Contacts

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Moussa A Riachy, MD, FCCP

Role: primary

Mirella Skandar, MD

Role: backup

Related Links

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Other Identifiers

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HDF575

Identifier Type: -

Identifier Source: org_study_id