Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)

Obstructive Sleep Apnea Clinical Trial

— SABIO  

Official title:

Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01769807
• Other study ID #: CEDOC
• Secondary ID: Fundação Ciência
• Status: Completed
• Phase: N/A
• First received: November 17, 2012
• Last updated: January 16, 2013
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: January 2013
• Source: University of Lisbon
• Contact: n/a
• Is FDA regulated: No
• Health authority: Portugal: Ethics Committee for Clinical Research
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: December 2008
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diagnosis of obstructive sleep apnea

Exclusion Criteria:

• current smoker

• respiratory disease

• cardiac disease (except for arterial hypertension)

• renal disorder

• hepatic disorder

• psychiatric disorder

• diabetes mellitus

• dyslipidemia

• rhinitis

• sinusitis

• acute illness

• daytime hypoxemia or hypercapnia

• therapy with oral nitrates

• therapy with angiotensin-converting enzyme inhibitors

• therapy with beta-blockers

• therapy with statins

• therapy with non-steroidal anti-inflammatory drugs

• presence of central respiratory events

• previous CPAP therapy

• previous uvulopalatopharyngoplasty

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• CPAP
CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.

Locations

Country	Name	City	State
Portugal	Hospital Pulido Valente	Lisbon

Sponsors (1)

Lead Sponsor	Collaborator
University of Lisbon

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma nitrate (NOx) levels	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.	one month	No
Secondary	24 h Blood pressure	Ambulatory BP were obtained at baseline and after 1 month of CPAP.	one month after CPAP	No
Secondary	Urinary norepinephrine (U-NE) levels	After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.	One month	No