Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea (OSA)

September 11, 2012 updated by: George S. Stergiou, University of Athens
Subjects referred to a sleep clinic had polysomnography (PSG), clinic BP measurements, 24-hour ABP monitoring and HBP monitoring using a device (Microlife WatchBP HomeN) that allows daytime (3 days, 2 duplicate readings/day) and automated nighttime BP measurement (3 nights, 3 readings/night).

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Athens, Greece, 11527
        • Recruiting
        • Hypertension Center, Third Department of Medicine, University of Athens, Greece
      • Athens, Greece, 11527
        • Recruiting
        • First University Department of Respiratory Medicine, Sotiria Hospital
        • Contact:
          • Manos Alchanatis, Assoc. Prof. Respir. Medicine
          • Phone Number: +302107763685
        • Principal Investigator:
          • Manos Alchanatis, Assoc. Prof. Respir. Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects referred to a sleep clinic

Description

Inclusion Criteria:

  • Age ≤ 65 years
  • Suspected OSA
  • Treated or untreated for hypertension

Exclusion Criteria:

  • History of cardiovascular disease (heart failure, coronary heart disease, arrhythmia or stroke)
  • History of asthma or chronic obstructive pulmonary disease (FEV1/FVC <70%)
  • History of diabetes mellitus, collagen diseases and sarcoidosis
  • Serum creatinine >1.6 mg/dl, proteinuria
  • Previous treatment with CPAP
  • Pregnancy or menstruation during the study
  • Treatment with steroids, lithium or any other drugs affecting BP
  • Change in antihypertensive treatment(if any) in the last 8 weeks before study entry

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Athens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Anticipated)

June 1, 2013

Study Completion (Anticipated)

June 1, 2013

Study Registration Dates

First Submitted

September 11, 2012

First Submitted That Met QC Criteria

September 11, 2012

First Posted (Estimate)

September 14, 2012

Study Record Updates

Last Update Posted (Estimate)

September 14, 2012

Last Update Submitted That Met QC Criteria

September 11, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OSA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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