Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02417584
Other study ID # PAPBP-01
Secondary ID
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


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
See also
  Status Clinical Trial Phase
Completed NCT01620554 - Dose-range Finding Study of BF2.649 Effect on Patients With Obstructive Sleep Apnea (OSA) Phase 2
Not yet recruiting NCT01985347 - The SAD Study - SLEEP, ANXIETY & DEPRESSION Study A Prospective Cohort Study N/A
Completed NCT01312558 - The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial N/A
Completed NCT02967536 - Investigating the Neuropathology of Obstructive Sleep Apnoea
Completed NCT02855515 - Drug-Induced Sleep Endoscopy for the Optimisation of Treatment of Patients With Obstruction Sleep Apnoea N/A
Terminated NCT03127800 - Morphine in Moderate Obstructive Sleep Apnoea Phase 3
Recruiting NCT04262986 - A Brief Lifestyle Modification Programme in Overweight Subjects With Obstructive Sleep Apnoea - Needs Assessment
Completed NCT03145129 - PAIR Study-PAP And IOP Relationship: Study 2
Completed NCT06376305 - EndoBarrier in Obstructive Sleep Apnoea Study N/A
Completed NCT02713152 - Prevalence of Obstructive Sleep Apnoea in Glaucoma N/A
Completed NCT01661712 - Continuous Transcutaneous Electrical Stimulation in Sleep Apnoea N/A
Terminated NCT01530451 - Clinical Trial of Desmopressin on Nocturia in Obstructive Sleep Apnoea Patients Phase 3
Completed NCT02518633 - Obstructive Sleep Apnoea and Adipose Tissue Dysfunction N/A
Completed NCT01557166 - Effect of Liraglutide in Obese Subjects With Moderate or Severe Obstructive Sleep Apnoea: SCALEā„¢ - Sleep Apnoea Phase 3
Recruiting NCT01829854 - To Investigate the Incidence of Obstructive Sleep Apnoea in Patient Undergoing Open Heart Surgery N/A
Completed NCT01619748 - Peripheral Vascular Function in Obstructive Sleep Apnoea N/A
Completed NCT04071860 - Developing a Non-contact Sleep Apnoea Detector, Suitable for Home Studies- The Safescan Study
Not yet recruiting NCT04607343 - Clinical Trial of a Rehabilitation Device Based on Electrostimulation for Obstructive Sleep Apnoea N/A
Completed NCT01546792 - Lifestyle Intervention in Obstructive Sleep Apnoea Phase 2/Phase 3
Completed NCT00300599 - Effect of Continuous Positive Airway Pressure (CPAP) on Systemic Blood Pressure, Coagulability and Carotid Intima-media Thickness in Patients With Sleep Apnea N/A