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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-07-31

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

CPAP

Intervention Type DEVICE

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

Interventions

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CPAP

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

Intervention Type DEVICE

Other Intervention Names

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Automated pressure setting device (AutoSet Spirit, ResMed)

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No