Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
SABIO
Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea
2 other identifiers
interventional
67
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2004
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 17, 2012
CompletedFirst Posted
Study publicly available on registry
January 17, 2013
CompletedJanuary 17, 2013
January 1, 2013
4.4 years
November 17, 2012
January 16, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
24 h Blood pressure
one month after CPAP
Urinary norepinephrine (U-NE) levels
One month
Study Arms (1)
CPAP treatment
EXPERIMENTAL67 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.
Interventions
CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
Eligibility Criteria
You may qualify if:
- \- Diagnosis of obstructive sleep apnea
You may not qualify if:
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Pulido Valente
Lisbon, Lisbon District, 1769-001, Portugal
Related Publications (1)
Pinto P, Barbara C, Montserrat JM, Patarrao RS, Guarino MP, Carmo MM, Macedo MP, Martinho C, Dias R, Gomes MJ. Effects of CPAP on nitrate and norepinephrine levels in severe and mild-moderate sleep apnea. BMC Pulm Med. 2013 Mar 13;13:13. doi: 10.1186/1471-2466-13-13.
PMID: 23497046DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Paula G Pinto, PhD
University of Lisbon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
November 17, 2012
First Posted
January 17, 2013
Study Start
July 1, 2004
Primary Completion
December 1, 2008
Study Completion
December 1, 2008
Last Updated
January 17, 2013
Record last verified: 2013-01