Efficacy of PAP Therapy on Blood Pressure

NCT ID: NCT02417584

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1168 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2014-05-31

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.

Conditions

Obstructive Sleep Apnoea

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

positive airway pressure (PAP)

Treatment with positive airway pressure (PAP)

Group Type: EXPERIMENTAL

positive airway pressure (PAP)

Intervention Type: 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.

Interventions

positive airway pressure (PAP)

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Crete

OTHER

Sponsor Role: lead

Responsible Party

Izolde Bouloukaki

MD, PhD, Consultant at NHS

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sophia E Schiza, MD, PhD

Role: STUDY_CHAIR

University of Crete

Locations

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

Heraklion, , Greece

Countries

Greece

Other Identifiers

PAPBP-01

Identifier Type: -

Identifier Source: org_study_id