NCT00768807

Brief Summary

The purpose of this study is to determine whether patients with obstructive sleep apnea have any changes in left ventricular function and structure after 06 months of continuous positive airway pressure treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

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

First Submitted

Initial submission to the registry

October 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2008

Completed
12 months until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

May 8, 2012

Status Verified

May 1, 2012

Enrollment Period

Same day

First QC Date

October 6, 2008

Last Update Submit

May 4, 2012

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Improvement of left ventricular diastolic echo variable

    06 months

Study Arms (2)

Sham CPAP

SHAM COMPARATOR

Patients submitted to SHAM CPAP use for 06 months

Device: CPAP (continuous positive airway pressure)

CPAP

ACTIVE COMPARATOR

OSA patients submitted to 06 months of CPAP treatment

Device: CPAP (continuous positive airway pressure)

Interventions

CPAP (continuous positive airway pressure)DEVICE

Patients treated by CPAP for 06 months

CPAPSham CPAP

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Apnea-hypopnea index higher than 5 events per hour

You may not qualify if:

  • Body mass index higher than 40 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto do Sono/AFIP

São Paulo, São Paulo, 04516001, Brazil

Location

Related Publications (1)

  • Oliveira W, Campos O, Cintra F, Matos L, Vieira ML, Rollim B, Fujita L, Tufik S, Poyares D. Impact of continuous positive airway pressure treatment on left atrial volume and function in patients with obstructive sleep apnoea assessed by real-time three-dimensional echocardiography. Heart. 2009 Nov;95(22):1872-8. doi: 10.1136/hrt.2009.173625. Epub 2009 Jul 29.

    PMID: 19643769DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

October 6, 2008

First Posted

October 8, 2008

Study Start

October 1, 2009

Primary Completion

October 1, 2009

Study Completion

September 1, 2010

Last Updated

May 8, 2012

Record last verified: 2012-05

Locations

BR(1)