NCT02301923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 2, 2014

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 26, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 26, 2014

Status Verified

November 1, 2014

Enrollment Period

Same day

First QC Date

November 2, 2014

Last Update Submit

November 25, 2014

Conditions

Keywords

Continuous Positive Airway Pressure

Outcome Measures

Primary Outcomes (1)

  • Compliance time to CPAP

    Survival study taking the noncompliance to CPAP treatment as an event

    6 years

Secondary Outcomes (5)

  • Predictive factors related to the patient for compliance to CPAP (Sociologic and economic status, medical co morbidities, Anthropometric characteristics)

    6 years

  • Predictive factors related to the provider for compliance to CPAP (Attitude of the provider (active, passive), consistency/quality of the follow up)

    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)

    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)

    6 years

  • Cardiovascular outcome/benefits (cardiovascular events; defined by hypertension, coronary event, stroke, diabetes, cardiac insufficiency, arrhythmias)

    6 years

Study Arms (2)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • All HDF patients with OSA, treated for at least one day by CPAP, from the period of June 2008 to June 2013.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hotel Dieu de France Hospital

Beirut, Lebanon

Location

Related Links

MeSH Terms

Conditions

Sleep Apnea, ObstructivePatient Compliance

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Moussa Riachy, Ass Prof

    Saint Joseph Univ

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Moussa A Riachy, Ass Prof

CONTACT

Mirella Skandar, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Moussa Riachy MD FCCP

Study Record Dates

First Submitted

November 2, 2014

First Posted

November 26, 2014

Study Start

November 1, 2014

Primary Completion

November 1, 2014

Study Completion

March 1, 2015

Last Updated

November 26, 2014

Record last verified: 2014-11

Locations