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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by George S. Stergiou, University of Athens.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01685736
First Posted: September 14, 2012
Last Update Posted: September 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
George S. Stergiou, University of Athens
  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 George S. Stergiou, 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685736


Locations
Greece
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         
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         
Sponsors and Collaborators
University of Athens
  More Information

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
First Submitted: September 11, 2012
First Posted: September 14, 2012
Last Update Posted: September 14, 2012
Last Verified: September 2012

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