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

January 16, 2013 updated by: Paula Pinto, University of Lisbon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

67

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Portugal
      • Lisbon, Portugal, 1769-001
        • Hospital Pulido Valente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Device: CPAP
CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
Other Names:
  • Automated pressure setting device (AutoSet Spirit, ResMed)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Plasma nitrate (NOx) levels
Time Frame: 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.
one month

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lisbon

Investigators

  • Principal Investigator: Paula G Pinto, PhD, University of Lisbon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2004

Primary Completion (ACTUAL)

December 1, 2008

Study Completion (ACTUAL)

December 1, 2008

Study Registration Dates

First Submitted

November 17, 2012

First Submitted That Met QC Criteria

January 16, 2013

First Posted (ESTIMATE)

January 17, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 17, 2013

Last Update Submitted That Met QC Criteria

January 16, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEDOC
  • Fundação Ciência e Tecnologia (OTHER_GRANT: Fundação para a Ciência e Tecnologia (FCT))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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