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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 April 2015 |
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Main ID: |
NCT02417584 |
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Date of registration:
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11/04/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy of PAP Therapy on Blood Pressure
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Scientific title:
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The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea |
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Date of first enrolment:
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June 2009 |
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Target sample size:
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1168 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02417584 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Greece
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Contacts
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Name:
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Sophia E Schiza, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Crete |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- newly diagnosed OSAHS by polysomnography according to standard criteria
- no history of previous PAP therapy
- normotensive and hypertensive patients
- an above-elementary school education.
Exclusion Criteria:
- refusal to participate
- refusal of PAP therapy
- secondary hypertension
- central sleep apnea syndromes
- obesity hypoventilation syndrome
- restrictive ventilator syndromes
- history of established cardiovascular disease
- severe congestive heart failure
- a history of life-threatening arrhythmias
- severe cardiomyopathy
- significant chronic kidney disease
- long-term oxygen therapy
- family or personal history of mental illness
- drug or alcohol abuse
- severe cognitive impairment
- concurrent oncological diseases
- need for chronic use of medication that may affect BP levels
- pregnancy
- history of narcolepsy or restless leg syndrome
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Obstructive Sleep Apnoea
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Intervention(s)
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Device: positive airway pressure (PAP)
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Primary Outcome(s)
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drop in blood pressure
[Time Frame: two years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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