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

Not Applicable

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Device: CPAP

• Registration Number: NCT01769807
• Lead Sponsor: University of Lisbon

Brief 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.

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.

Study Timeline

• Study Start: 2004-07
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Study First Submitted: 2012-11-17
• Status Verified: 2013-01
• Study First Submitted QC: 2013-01-16
• Last Update Submitted: 2013-01-16
• Study First Posted: 2013-01-17
• Last Update Posted: 2013-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 67

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP treatment	CPAP	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.

Primary Outcome Measures

Name	Time	Method
Plasma nitrate (NOx) levels	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.

Secondary Outcome Measures

Name	Time	Method
24 h Blood pressure	one month after CPAP	Ambulatory BP were obtained at baseline and after 1 month of CPAP.
Urinary norepinephrine (U-NE) levels	One month	After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.

Trial Locations

Locations (1)

Hospital Pulido Valente; 🇵🇹 Lisbon, Portugal