Efficacy of PAP Therapy on Blood Pressure

Obstructive Sleep Apnoea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02417584
• Other study ID #: PAPBP-01
• Status: Completed
• Phase: N/A
• First received: April 11, 2015
• Last updated: April 14, 2015
• Start date: June 2009
• Est. completion date: May 2014

Study information

• Verified date: April 2015
• Source: University of Crete
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1168
• Est. completion date: May 2014
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obstructive Sleep Apnoea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Greece	Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,	Heraklion

Sponsors (1)

Lead Sponsor	Collaborator
University of Crete

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	drop in blood pressure		two years	No