NCT03776084

Brief Summary

The aim of the study is to know the adherence to treatment and compliance of patients diagnosed with SAHS and with indication of CPAP from the sleep unit of the Hospital de Sabadell.

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
405

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2019

Typical duration 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

2 years

First QC Date

December 13, 2018

Last Update Submit

March 23, 2021

Conditions

Keywords

treatment adherence and complianceattitudesContinuous Positive Airway Pressurecross-cultural validation

Outcome Measures

Primary Outcomes (2)

  • Adherence rate to CPAP treatment

    % of patients who still use CPAP

    1 year after starting treatment

  • Ratio of patients with compliance with the treatment

    % of patients use CPAP ≥4h / night

    1 year after starting treatment

Study Arms (1)

Patients SAHS with CPAP

Continuous Positive Airway Pressure treatment

Device: Continuous Positive Airway Pressure

Interventions

CPAP indication

Patients SAHS with CPAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with OSAS and who underwent treatment with Continuous Positive Airway Pressure at the Hospital de Sabadell.

You may qualify if:

  • Patients over 18 years of age treated with CPAP based on the diagnosis of OSAS (clinical picture and AHI\> 10).

You may not qualify if:

  • Diagnosis of a psychiatric illness or dementia.
  • Communication problems or inability to read and speak Spanish.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CorporacionPT

Sabadell, Barcelona, 08208, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, ObstructiveTreatment Adherence and ComplianceBehavior

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesHealth Behavior

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Officials

  • Montserrat Montaña, PHD

    Corporacion Parc Tauli

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Montserrat Montaña, PhD

CONTACT

Maria José Masdeu, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Research

Study Record Dates

First Submitted

December 13, 2018

First Posted

December 14, 2018

Study Start

June 1, 2019

Primary Completion

June 1, 2021

Study Completion

September 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations