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Completed

NCT Number: NCT02417584

Efficacy of PAP Therapy on Blood Pressure

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,

Heraklion, 71110, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Positive Airway Pressure (PAP)

Device

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 outcomes

  1. drop in blood pressure

    Time frame: two years

Sponsors and collaborators

Lead sponsor

University of Crete

Other

Registry information

Official study title

The Role of Compliance With Positive Airway Pressure Use on Blood Pressure in Patients With Obstructive Sleep Apnea

Important dates

Study start
2009
Primary completion
2011
Study completion
2014
First posted
Apr 15, 2015
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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