NCT00570115

Brief Summary

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left atrial morphology and function evaluated by echocardiography three dimensional

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
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 10, 2007

Completed
Last Updated

May 8, 2012

Status Verified

December 1, 2007

First QC Date

December 7, 2007

Last Update Submit

May 7, 2012

Conditions

Keywords

Sleep Apnea Syndromes diastolic disfunction left atrium

Outcome Measures

Primary Outcomes (1)

  • Left Atrial enlargement

    1 day

Study Arms (1)

A

The subjects for this group are matched for age, gender, body mass index. The presence of obstructive sleep apnea will divide the cohort in 02 subgroups: non-Obstructive Sleep Apnea and Obstructive Sleep Apnea

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The investigators recruited 56 recently diagnosed OSA patients, confirmed by full polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal University of Sao Paulo, Brazil, according to the following inclusion criteria: both genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) \>5 events/hour of sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full PSG, matched by age, gender, and BMI.

You may qualify if:

  • Age from 30 to 70
  • Apnea-hypopnea index \> 5 by polysomnography

You may not qualify if:

  • Any cardiac disease
  • Poor imaging quality by mean of echocardiography
  • non-sinusal Rhythm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono/Federal University of Sao Paulo

São Paulo, São Paulo, 04020060, Brazil

Location

Related Publications (1)

  • Anwar AM, Soliman OI, Geleijnse ML, Nemes A, Vletter WB, ten Cate FJ. Assessment of left atrial volume and function by real-time three-dimensional echocardiography. Int J Cardiol. 2008 Jan 11;123(2):155-61. doi: 10.1016/j.ijcard.2006.12.017. Epub 2007 Apr 17.

    PMID: 17442422BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Sergio Tufik, PhD,MD.

    Federal University of São Paulo

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 7, 2007

First Posted

December 10, 2007

Study Start

June 1, 2007

Study Completion

November 1, 2007

Last Updated

May 8, 2012

Record last verified: 2007-12

Locations