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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01336335

Enrollment

Registered

2011-04-15

Start date

2010-07-31

Completion date

2011-07-31

Last updated

2011-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Pressure Monitoring, Ambulatory, Catecholamines, Exercise Test, Radionuclide Imaging (MIBG Scintigraphy), Sympathetic Nerve Activity

Keywords

sleep apnea, obstructive, sympathetic nerve activity, treatment

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)

Interventions

DEVICECPAP

CPAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

30 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Severe OSA males

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
improvement in sympathetic activity in muscle sympathetic nerve activity (MSNA)	3 months	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

Measure	Time frame	Description
improvement in sympathetic activity evaluated in different sites of activation	3 months	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)

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026