Efficacy of PAP Therapy on Blood Pressure | NCT02417584

Studies
Efficacy of PAP Therapy on Blood Pressure

NCT02417584

Sponsor

University of Crete

Status

Completed

Last Update Posted

Apr 15, 2015Estimated

Enrollment

1,168Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnoea

Interventions

positive airway pressure (PAP)

Countries

Greece

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Jun 2011Actual

Completion Date

May 2014Actual

First Submitted Date

Apr 11, 2015

First Submission Date that Met QC Criteria

Apr 14, 2015

First Posted Date

Apr 15, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 14, 2015

Last Update Posted Date

Apr 15, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,168Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
positive airway pressure (PAP)	Experimental	Treatment with positive airway pressure (PAP)	Device: positive airway pressure (PAP)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Measure	Description	Time Frame
drop in blood pressure		two years

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sophia E Schiza, MD, PhD	University of Crete	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sleep Disorders Center, Department of Thoracic Medicine, University of Crete,		Heraklion		71110	Greece

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided