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

Sleep Apnea, Obstructive Clinical Trial

— CPAPcompl  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02301923
• Other study ID #: HDF575
• Status: Not yet recruiting
• Phase: N/A
• First received: November 2, 2014
• Last updated: November 25, 2014
• Start date: November 2014
• Est. completion date: March 2015

Study information

• Verified date: November 2014
• Source: Saint-Joseph University
• Contact: Moussa A Riachy, Ass Prof
• Phone: 9613361672
• Email: riachy[@]dm.net.lb
• Is FDA regulated: No
• Health authority: Lebanon: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: March 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Apnea
• Patient Compliance
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Locations

Country	Name	City	State
Lebanon	Hotel Dieu de France Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Saint-Joseph University

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance time to CPAP	Survival study taking the noncompliance to CPAP treatment as an event	6 years	No
Secondary	Predictive factors related to the patient for compliance to CPAP (Sociologic and economic status, medical co morbidities, Anthropometric characteristics)	Factors related to the patient: Sociologic and economic status, medical co morbidities, Anthropometric characteristics.	6 years	No
Secondary	Predictive factors related to the provider for compliance to CPAP (Attitude of the provider (active, passive), consistency/quality of the follow up)	Factors related to the provider: Attitude of the provider (active, passive), consistency/quality of the follow up.	6 years	No
Secondary	Predictive factors related to the device for compliance to CPAP (Mask type, use of a humidification, Device type/mode, Pressure set, Cost, Side effects)	Factors related to the device: Mask type, use of a humidification, Device type/mode, Pressure set, Cost, Side effects.	6 years	No
Secondary	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)	Factors related to OSA: Severity score, fatigue and Epworth score, Polysomnography profile (AHI, ODI, Arousal index…), use of alternative treatments.	6 years	No
Secondary	Cardiovascular outcome/benefits (cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias)	cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias; timeframe: after CPAP cessation	6 years	No

External Links

•   Bibliography