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

Study Overview
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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.

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.

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: CPAP


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CPAP treatment<br>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. | Device: CPAP<br>* CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.<br>* Other names: Automated pressure setting device (AutoSet Spirit, ResMed);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 h Blood pressure | Ambulatory BP were obtained at baseline and after 1 month of CPAP. | one month after CPAP | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sleep apnea, CPAP treatment, Plasma nitrate, Urinary norepinephrine, Blood pressure