NCT01336335

Brief Summary

Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the sympathetic system in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure in different sites of activation (heart, peripheral nerves and circulating catecholamines)

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

July 1, 2010

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 15, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

April 15, 2011

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

April 13, 2011

Last Update Submit

April 13, 2011

Conditions

Radionuclide Imaging (MIBG Scintigraphy)Exercise TestBlood Pressure Monitoring, AmbulatorySympathetic Nerve ActivityCatecholamines

Keywords

sleep apnea, obstructivesympathetic nerve activitytreatment

Outcome Measures

Primary Outcomes (1)

  • improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)

    Improvement in MSNA will be quantified as burst frequency over time (bursts per minute) and as burst frequency corrected for heart rate values (bursts per 100 heartbeats)in the begining and after 3 months.

    3 months

Secondary Outcomes (1)

  • improvement in sympathetic activity evaluated in different sites of activation

    3 months

Study Arms (2)

CPAP

EXPERIMENTAL

OSA treatment with CPAP

Device: CPAP

control

NO INTERVENTION

no intervention

Interventions

CPAPDEVICE

CPAP

CPAP

Eligibility Criteria

Age30 Years - 60 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Severe OSA males

You may not qualify if:

  • Smoking
  • Sustained Hypertension
  • Heart failure
  • Diabetes
  • Renal diseases
  • Under use of any medication
  • Under treatment for OSA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Institute

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

  • Rodrigo Pedrosa, MD, PhD

    Heart Institute (InCor)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 15, 2011

Study Start

July 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

April 15, 2011

Record last verified: 2010-07

Locations

BR(1)