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

Universidade de Lisboa

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Device: CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01769807

CEDOC

Fundação Ciência e Tecnologia (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 67 patients

Sex: Male

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

CPAP treatment

Experimental group

Description:

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.

Treatment:

Device: CPAP