NCT02417584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 11, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
Last Updated

April 15, 2015

Status Verified

April 1, 2015

Enrollment Period

2 years

First QC Date

April 11, 2015

Last Update Submit

April 14, 2015

Conditions

Obstructive Sleep Apnoea

Outcome Measures

Primary Outcomes (1)

  • drop in blood pressure

    two years

Study Arms (1)

positive airway pressure (PAP)

EXPERIMENTAL

Treatment with positive airway pressure (PAP)

Device: positive airway pressure (PAP)

Interventions

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.

positive airway pressure (PAP)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • newly diagnosed OSAHS by polysomnography according to standard criteria
  • no history of previous PAP therapy
  • normotensive and hypertensive patients
  • an above-elementary school education.

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Heraklion, 71110, Greece

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sophia E Schiza, MD, PhD

    University of Crete

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Consultant at NHS

Study Record Dates

First Submitted

April 11, 2015

First Posted

April 15, 2015

Study Start

June 1, 2009

Primary Completion

June 1, 2011

Study Completion

May 1, 2014

Last Updated

April 15, 2015

Record last verified: 2015-04

Locations

GR(1)