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The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Sao Paulo.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01336335
First received: April 13, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

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)


Condition Intervention Phase
Radionuclide Imaging (MIBG Scintigraphy)
Exercise Test
Blood Pressure Monitoring, Ambulatory
Sympathetic Nerve Activity
Catecholamines
Device: CPAP
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Effects of Continuous Positive Airway Pressure (CPAP) on Sympathetic Activity in Different Sites of Activation

Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • improvement in sympathetic activity evaluated in different sites of activation [ Time Frame: 3 months ] [ Designated as safety issue: No ]

    All measurement will be performed at the begining and after 3 months. Blood: blood and 24 hour urine will be collected for norepinephrine quantification.

    Heart: Early (15 min) and delayed (3 hr) planar images will be taken after injection of (123)I-MIBG. The mean counts of the whole heart and the mediastinum will be obtained to calculate heart-to-mediastinum count ratios from the early images (H/Me) and from the delayed images (H/Md) and the myocardial washout rate (WR).

    Blood pressure: 24 hour ambulatory blood pressure monitoring and blood pressure during exercise test (treadmill test)



Estimated Enrollment: 20
Study Start Date: July 2010
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CPAP
OSA treatment with CPAP
Device: CPAP
CPAP
No Intervention: control
no intervention

  Eligibility

Ages Eligible for Study:   30 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Severe OSA males

Exclusion Criteria:

  • Smoking

    • Sustained Hypertension
    • Heart failure
    • Diabetes
    • Renal diseases
    • Under use of any medication
    • Under treatment for OSA
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01336335

Locations
Brazil
Heart Institute
São Paulo, Brazil
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rodrigo Pedrosa, MD, PhD Heart Institute (InCor)
  More Information

No publications provided

Responsible Party: Geraldo Lorenzi-Filho, Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT01336335     History of Changes
Other Study ID Numbers: Sympathetic activity and OSA
Study First Received: April 13, 2011
Last Updated: April 13, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by University of Sao Paulo:
sleep apnea, obstructive
sympathetic nerve activity
treatment

ClinicalTrials.gov processed this record on November 19, 2014