NCT00487929

Brief Summary

The purpose of this study is to compare the levels of 8-isoprostane and other oxidative stress biomarkers in plasma and condensed exhaled air between patients with SAHS and cardiovascular complications, patients with SAHS without cardiovascular complications and control subjects. To evaluate the effect of three months of treatment with CPAP on the oxidative stress biomarkers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 19, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

April 2, 2013

Status Verified

October 1, 2008

Enrollment Period

4.8 years

First QC Date

June 18, 2007

Last Update Submit

April 1, 2013

Conditions

Sleep ApneaCardiovascular Diseases

Keywords

sleep apneamorbiditycardiovascularcpapoxidative stress

Outcome Measures

Primary Outcomes (1)

  • Plasmatic 8-isoprostane concentration

    three months

Secondary Outcomes (1)

  • Plasmatic and condensed exhaled air concentrations of homocysteine, HIF-1, NFkB, AP-1, VEGF, ET-1, TNF-alpha, IL-1, IL-6, ICAM-1, VCAM-1, nitrates and nitrites.

    three months

Study Arms (2)

CPAP

EXPERIMENTAL

Continuous positive airway pressure

Device: nasal CPAP

Sham CPAP

SHAM COMPARATOR

Sham nasal continuous positive airway pressure

Device: Sham CPAP

Interventions

nasal CPAPDEVICE

Nocturnal

CPAP
Sham CPAPDEVICE

Nocturnal

Sham CPAP

Eligibility Criteria

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

You may qualify if:

  • Sleep apnea-hypopnea syndrome (AHI \> 5)
  • Excessive sleepiness (ESS \> 11)
  • No previous CPAP treatment

You may not qualify if:

  • Blood pressure \> 180/120 mmHg.
  • Secondary hypertension
  • Professional driver
  • COPD, asthma, bronchiectasis, lung cancer, restrictive lung disorder, chest wall disease
  • Neuromuscular disease or thyroid function abnormalities
  • Morbid obesity (BMI \> 40 Kg/m2).
  • Respiratory infection in the 2 last months.
  • Anemia (Hb \< 10 g/dl) or polyglobulia (Hct \> 55%).
  • Diurnal hypercapnia (PaCO2 \> 45 mmHg) or moderate hypoxemia (PaO2 \< 70 mmHg).

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 DiseasesMicrocephaly, Primary Autosomal Recessive, 6

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Francisco García-Rio, PhD

    Servicio de Neumología. Hospital Universitario La Paz

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 18, 2007

First Posted

June 19, 2007

Study Start

June 1, 2007

Primary Completion

April 1, 2012

Study Completion

October 1, 2012

Last Updated

April 2, 2013

Record last verified: 2008-10

Locations

ES(1)