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

This study is currently recruiting participants.
Verified September 2012 by University of Athens
Sponsor:
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
ClinicalTrials.gov Identifier:
NCT01685736
First received: September 11, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

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).


Condition
Obstructive Sleep Apnoea
Hypertension

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ambulatory Versus Home Blood Pressure Monitoring in Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by University of Athens:

Estimated Enrollment: 50
Study Start Date: February 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Subjects referred to a sleep clinic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01685736

Locations
Greece
Hypertension Center, Third Department of Medicine, University of Athens, Greece Recruiting
Athens, Greece, 11527
Contact: George S Stergiou, MD    +302107763117    gstergi@med.uoa.gr   
Principal Investigator: George S Stergiou, MD         
First University Department of Respiratory Medicine, Sotiria Hospital Recruiting
Athens, Greece, 11527
Contact: Manos Alchanatis, Assoc. Prof. Respir. Medicine    +302107763685      
Principal Investigator: Manos Alchanatis, Assoc. Prof. Respir. Medicine         
Sponsors and Collaborators
University of Athens
  More Information

No publications provided

Responsible Party: George S. Stergiou, Associate Professor of Medicine and Hypertension, University of Athens
ClinicalTrials.gov Identifier: NCT01685736     History of Changes
Other Study ID Numbers: OSA
Study First Received: September 11, 2012
Last Updated: September 11, 2012
Health Authority: Greece: Ethics Committee

Additional relevant MeSH terms:
Apnea
Hypertension
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 22, 2014