NCT01201200

Brief Summary

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in right ventricular function evaluated by three dimensional echocardiography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2007

Shorter than P25 for all trials

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

June 1, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
Last Updated

May 8, 2012

Status Verified

June 1, 2010

First QC Date

September 13, 2010

Last Update Submit

May 7, 2012

Conditions

Obstructive Sleep Apnea

Keywords

Obstructive Sleep ApneaRight Ventricular FunctionPulmonary Hypertension

Study Arms (4)

Group 1 - Obstructive Sleep Apnea (OSA)

Fifty-six patients with Obstructive Sleep Apnea

Group 2 - Non-OSA Controls

Fifty individuals without OSA with similar age, gender and body mass index (BMI)

Group 3 - Treatment

Fifteen patients with moderate and severe sleep apnea from group 1 underwent treatment with continuous positive airway pressure

Group 4 - Placebo

Fifteen patients with moderate/severe sleep apnea underwent to placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Initially, 56 patients with obstructive sleep apnea (OSA) and 50 non-OSA controls underwent real-time three-dimensional echocardiography. 30 Patients with moderate and severe OSA underwent to continuous positive airway pressure treatment over 6 months. Echocardiogram will be repeated on the third and sixth months from the treatment onset.

You may qualify if:

  • Individuals \> 18 years old and \< 70.

You may not qualify if:

  • Body mass index greater than 35
  • Past of clinically significant cardiac conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Paulista de Medicina

São Paulo, São Paulo, 04516001, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveHypertension, Pulmonary

Condition Hierarchy (Ancestors)

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

Study Officials

  • Orlando Campos, PhD

    Escola Paulista de Medicina

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

June 1, 2007

Study Completion

November 1, 2007

Last Updated

May 8, 2012

Record last verified: 2010-06

Locations

BR(1)