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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02301923
Acronym
CPAPcompl
Enrollment
450
Registered
2014-11-26
Start date
2014-11-30
Completion date
2015-03-31
Last updated
2014-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patient Compliance, Sleep Apnea, Obstructive

Keywords

Continuous Positive Airway Pressure

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.

Interventions

None listed

Sponsors

Saint-Joseph University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Compliance time to CPAP6 yearsSurvival study taking the noncompliance to CPAP treatment as an event

Secondary

MeasureTime frameDescription
Predictive factors related to the patient for compliance to CPAP (Sociologic and economic status, medical co morbidities, Anthropometric characteristics)6 yearsFactors 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)6 yearsFactors 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)6 yearsFactors 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)6 yearsFactors 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)6 yearscardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias; timeframe: after CPAP cessation

Countries

Lebanon

Contacts

Primary ContactMoussa A Riachy, Ass Prof
riachy@dm.net.lb9613361672
Backup ContactMirella Skandar, M.D.
mirella.iskandar@gmail.com9617231331

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026