Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO) (SABIO)
|ClinicalTrials.gov Identifier: NCT01769807|
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Device: CPAP||Not Applicable|
The investigators aimed to compare NOx and U-NE levels and blood pressure (BP) between male patients with mild-moderate and severe OSA and determine the impact of 1 month of CPAP therapy on these parameters.
The investigators undertook a prospective study of 67 consecutive OSA patients (36 mild-moderate, 31 severe). Measurements of plasma NOx at 11 pm, 4 am and 7 am, 24-h U-NE and ambulatory BP were obtained at baseline and after 1 month of CPAP.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||67 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea|
|Study Start Date :||July 2004|
|Actual Primary Completion Date :||December 2008|
|Actual Study Completion Date :||December 2008|
Experimental: CPAP treatment
67 consecutive male patients with OSA were recruited: 36 with mild-moderate OSA and 31 with severe OSA. Data were collected in all subjects at baseline and after 1 month of CPAP.
CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
Other Name: Automated pressure setting device (AutoSet Spirit, ResMed)
- Plasma nitrate (NOx) levels [ Time Frame: one month ]After sleep apnea diagnosis, measurements of plasma NOx at 11 pm, 4 am and 7 am were obtained at baseline and after 1 month of CPAP.
- 24 h Blood pressure [ Time Frame: one month after CPAP ]Ambulatory BP were obtained at baseline and after 1 month of CPAP.
- Urinary norepinephrine (U-NE) levels [ Time Frame: One month ]After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769807
|Hospital Pulido Valente|
|Lisbon, Portugal, 1769-001|
|Principal Investigator:||Paula G Pinto, PhD||University of Lisbon|