Back to resultsEfficacy of PAP Therapy on Blood Pressure
Primary Purpose
Obstructive Sleep Apnoea
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
positive airway pressure (PAP)
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnoea
Eligibility Criteria
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
Sites / Locations
- Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
positive airway pressure (PAP)
Arm Description
Treatment with positive airway pressure (PAP)
Outcomes
Primary Outcome Measures
drop in blood pressure
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02417584
Brief Title
Efficacy of PAP Therapy on Blood Pressure
Official Title
The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Crete
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study was to determine the long term effects of compliance with positive airway pressure therapy on blood pressure in both hypertensive and normotensive patients with obstructive sleep apnoea hypopnoea syndrome.
Detailed Description
Scientific data about the causal role of obstructive sleep apnoea hypopnoea syndrome (OSAHS) in the development of systemic hypertension and the effects of positive airway pressure (PAP) treatment on blood pressure (BP) control are continuously increasing; however they are controversial. We aimed to determine the long term effects of compliance with PAP therapy on BP in both hypertensive and normotensive patients with OSAHS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnoea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1168 (Actual)
8. Arms, Groups, and Interventions
Arm Title
positive airway pressure (PAP)
Arm Type
Experimental
Arm Description
Treatment with positive airway pressure (PAP)
Intervention Type
Device
Intervention Name(s)
positive airway pressure (PAP)
Intervention Description
Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome.
Primary Outcome Measure Information:
Title
drop in blood pressure
Time Frame
two years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sophia E Schiza, MD, PhD
Organizational Affiliation
University of Crete
Official's Role
Study Chair
Facility Information:
Facility Name
Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,
City
Heraklion
ZIP/Postal Code
71110
Country
Greece
12. IPD Sharing Statement
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Efficacy of PAP Therapy on Blood Pressure
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