Sleep Apnea, ObstructiveCPAPcomplNCT02301923
Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
An observational study of Sleep Apnea, Obstructive and Patient Compliance, run by Saint-Joseph University at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Obstructive, Patient Compliance
- How many people
- 450 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2014to Mar 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All HDF patients with OSA, treated for at least one day by CPAP, from the period of June 2008 to June 2013.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Lebanon1 site
Hotel Dieu de France Hospital
Beirut
Moussa A Riachy, MD, FCCP, 961 1 615300 ext. 9218, riachy@dm.net.lb
Mirella Skandar, MD, 96170231331, mirella.iskandar@gmail.com
About this study
Official title: Predictive Factors Determining Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
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.
Read the 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.
- Conditions
- Sleep Apnea, Obstructive, Patient Compliance
- Keywords
- Continuous Positive Airway Pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance time to CPAP
Survival study taking the noncompliance to CPAP treatment as an event
Measured: 6 years
Secondary outcomes (5)
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.
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 6 years
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.
Measured: 6 years
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
Measured: 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2014
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint-Joseph University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, May Samaha, Saint-Joseph University
- Investigators
- Moussa Riachy, Ass Prof, Principal investigator, Saint Joseph Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301923
- Sponsor's protocol ID
- HDF575
- Acronym
- CPAPcompl
- Status last verified
- Nov 2014
- First submitted
- 2 Nov 2014
- Last updated
- 26 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Factors Determining Continuous Positive Airway Pressure (CPAP) Compliance in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT02301923
- Acronym / sponsor ID
- CPAPcompl / HDF575
- Conditions
- Sleep Apnea, Obstructive, Patient Compliance
- Keywords
- Continuous Positive Airway Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Saint-Joseph UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2015 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All HDF patients with OSA, treated for at least one day by CPAP, from the period of June 2008 to June 2013.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance time to CPAP
Time frame: 6 years
Survival study taking the noncompliance to CPAP treatment as an event
5 secondary outcomes
Predictive factors related to the patient for compliance to CPAP (Sociologic and economic status, medical co morbidities, Anthropometric characteristics)
Time frame: 6 years
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
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
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
Cardiovascular outcome/benefits (cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias)
Time frame: 6 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2014.
- BibliographyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moussa Riachy, Ass Prof principal investigator
Saint Joseph Univ
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea, Obstructive and Patient Compliance, run by Saint-Joseph University at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Moussa A Riachy, Ass Prof (9613361672, riachy@dm.net.lb), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance time to CPAP (time frame: 6 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2014.