NCT01803815

Brief Summary

This prospective cohort study aimed to assess the phenotypic characteristics of OSA patients and their pattern of antihypertensive drugs consumption. The investigators also aimed to investigate a hypothetical association between ongoing anti-hypertensive regimen and Blood pressure control rates in these patients. Additionally, the investigators were also interested in trying to understand if the control of OSA may be influenced by the use of different classes of anti-hypertensive drugs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
369

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

April 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

February 27, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

November 3, 2014

Status Verified

October 1, 2014

Enrollment Period

2.8 years

First QC Date

February 27, 2013

Last Update Submit

October 31, 2014

Conditions

HypertensionObstructive Sleep Apnea

Keywords

obstructive sleep apneahypertensionantihypertensive drugs

Outcome Measures

Primary Outcomes (1)

  • Number of participants with uncontrolled BP before CPAP (Continuous Positive Airway Pressure) adaptation.

    patients will be followed up for an expected average time of 2 months

Eligibility Criteria

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

Consecutive patients, male and women, aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit, located in Lisbon, were enrolled.

You may qualify if:

  • aged above 18 years, that attended a first visit at CHLN Hospital Sleep Unit were enrolled

You may not qualify if:

  • severe psychiatric disease or inability to understand the information required for an informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Nova de Lisboa - Faculdade de Ciências Médicas

Lisbon, 1169-056, Portugal

Location

MeSH Terms

Conditions

HypertensionSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Lucilia N Diogo, PharmD, MSc

    Universidade Nova de Lisboa - CEDOC

    PRINCIPAL INVESTIGATOR

  • Paula Pinto, PhD, MD

    CHLN

    STUDY CHAIR

  • Cristina Bárbara, PhD, MD

    CHLN

    STUDY CHAIR

  • Emilia C Monteiro, PhD, MD

    Universidade Nova de Lisboa

    STUDY DIRECTOR

  • Ana L Papoila, PhD

    Universidade Nova de Lisboa

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2013

First Posted

March 4, 2013

Study Start

April 1, 2010

Primary Completion

February 1, 2013

Study Completion

April 1, 2013

Last Updated

November 3, 2014

Record last verified: 2014-10

Locations

PT(1)