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Completed

NCT Number: NCT01769807

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

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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Key information

Conditions

Obstructive Sleep Apnea Apnea Dyssomnias Nervous System Diseases Respiration Disorders Respiratory Tract Diseases Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders

Age range

20 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Pulido Valente

Lisbon, Lisbon District, 1769-001, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CPAP

Device

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)

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Lisbon

Other

Registry information

Official study title

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

Acronym: SABIO

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 17, 2013
Registry last updated
Jan 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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