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

Information source: University of Lisbon
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obstructive Sleep Apnea

Intervention: CPAP (Device)

Phase: N/A

Status: Completed

Sponsored by: University of Lisbon

Official(s) and/or principal investigator(s):
Paula G Pinto, PhD, Principal Investigator, Affiliation: University of Lisbon


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.

Clinical Details

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

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

Primary outcome: Plasma nitrate (NOx) levels

Secondary outcome:

24 h Blood pressure

Urinary norepinephrine (U-NE) levels

Detailed 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.


Minimum age: 20 Years. Maximum age: 65 Years. Gender(s): Male.


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

Locations and Contacts

Hospital Pulido Valente, Lisbon 1769-001, Portugal
Additional Information

Starting date: July 2004
Last updated: January 16, 2013

Page last updated: August 23, 2015

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