NCT00547937

Brief Summary

Background: Previous studies present contradictory data concerning obstructive sleep apnea syndrome (OSAS), lipid oxidation and nitric oxide (NO) bioavailability. This study was aimed: (1) to compare the concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma of middle aged males with OSAS and no other known comorbidity and carefully matched healthy controls of the same age and gender; and (2) to test the hypothesis that nasal continuous positive airway pressure (CPAP) therapy, might attenuate oxidative stress and nitrate deficiency.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started May 2001

Typical duration for phase_4

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2001

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2003

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

October 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2007

Completed
Last Updated

November 9, 2007

Status Verified

October 1, 2007

First QC Date

October 22, 2007

Last Update Submit

November 7, 2007

Conditions

Sleep Apnea Syndromes

Keywords

Sleep ApneaOxidative StressNitric oxideCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • concentration of 8-isoprostane and total nitrate and nitrite (NOx) in plasma

    3 months

Study Arms (2)

Sham-CPAP

SHAM COMPARATOR

The sham CPAP device consisted of a conventional CPAP device, in which the area of the exhalation port was amplified, thereby nearly cancelling nasal pressure; an orifice resistor was connected between the tubing and the CPAP unit that loads the blower with the same airflow resistance as in effective CPAP

Device: nasal continuous positive airway pressure (CPAP) therapy

CPAP

ACTIVE COMPARATOR
Device: nasal continuous positive airway pressure (CPAP) therapy

Interventions

nasal continuous positive airway pressure (CPAP) therapyDEVICE

Nocturnal ventilation through a nasal mask to avoid sleep apneas

CPAPSham-CPAP

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • apnea-hypopnea index (AHI) ≥10 h-1
  • excessive daytime sleepiness defined by an Epworth scale score ≥11 points

You may not qualify if:

  • unwillingness or inability to participate in the study
  • obstructive or restrictive lung disease as identified by pulmonary function testing
  • use of cardioactive drugs
  • cardiac rhythm disturbances, including sinus bradycardia and sinus tachycardia
  • known arterial hypertension, or 24-hour mean blood pressure of 135 and/or 85 mm Hg or more
  • left ventricular ejection fraction \<50%, ischemic or valve heart disease, hypertrophic, restrictive or infiltrative cardiomyopathy, pericardial disease or stroke, by history, physical examination, ECG, chest radiography, conventional exercise stress testing, and echocardiography
  • diabetes mellitus, by history or 2 random blood glucose levels ≥126 mg/dl
  • morbid obesity (body mass index \>40 Kg/m2)
  • daytime hypoxemia (PaO2 \<70 mm Hg) or hypercapnia (PaCO2 \>45 mm Hg)
  • need to change medication
  • hospital admission for 10 or more days
  • average nightly CPAP usage less than 3.5 hours.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz

Madrid, Madrid, 28046, Spain

Location

MeSH Terms

Conditions

Sleep Apnea SyndromesCardiovascular Diseases

Interventions

Continuous Positive Airway PressureTherapeutics

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementRespiratory Therapy

Study Officials

  • Alberto Alonso, MD

    Sociedad Española de Neumología y Cirugía Torácica

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 22, 2007

First Posted

October 23, 2007

Study Start

May 1, 2001

Study Completion

December 1, 2003

Last Updated

November 9, 2007

Record last verified: 2007-10

Locations

ES(1)