ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01769807
Recruitment Status : Completed
First Posted : January 17, 2013
Last Update Posted : January 17, 2013
Sponsor:
Information provided by (Responsible Party):
Paula Pinto, 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Device: CPAP Not Applicable

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  (Clinical Trial)
Actual Enrollment : 67 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea
Study Start Date : July 2004
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

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 Name: Automated pressure setting device (AutoSet Spirit, ResMed)




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 24 h Blood pressure [ Time Frame: one month after CPAP ]
    Ambulatory BP were obtained at baseline and after 1 month of CPAP.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01769807


Locations
Portugal
Hospital Pulido Valente
Lisbon, Portugal, 1769-001
Sponsors and Collaborators
University of Lisbon
Investigators
Principal Investigator: Paula G Pinto, PhD University of Lisbon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paula Pinto, PhD, University of Lisbon
ClinicalTrials.gov Identifier: NCT01769807     History of Changes
Other Study ID Numbers: CEDOC
Fundação Ciência e Tecnologia ( Other Grant/Funding Number: Fundação para a Ciência e Tecnologia (FCT) )
First Posted: January 17, 2013    Key Record Dates
Last Update Posted: January 17, 2013
Last Verified: January 2013

Keywords provided by Paula Pinto, University of Lisbon:
Sleep apnea
CPAP treatment
Plasma nitrate
Urinary norepinephrine
Blood pressure

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Norepinephrine
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents