Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
Reduced plasma nitrate (NOx) levels and increased urinary norepinephrine (U-NE) levels have been described in severe obstructive sleep apnea (OSA), and are reverted by continuous positive airway pressure (CPAP). The investigators wanted to know the effect of CPAP on these biomarkers in mild-moderate OSA.
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea|
- Plasma nitrate (NOx) levels [ Time Frame: one month ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Ambulatory BP were obtained at baseline and after 1 month of CPAP.
- Urinary norepinephrine (U-NE) levels [ Time Frame: One month ] [ Designated as safety issue: No ]After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.
|Study Start Date:||July 2004|
|Study Completion Date:||December 2008|
|Primary Completion Date:||December 2008 (Final data collection date for primary outcome measure)|
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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769807
|Hospital Pulido Valente|
|Lisbon, Portugal, 1769-001|
|Principal Investigator:||Paula G Pinto, PhD||University of Lisbon|