Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
This study has been completed.
Sponsor:
University of Lisbon
Information provided by (Responsible Party):
Paula Pinto, University of Lisbon
ClinicalTrials.gov Identifier:
NCT01769807
First received: November 17, 2012
Last updated: January 16, 2013
Last verified: January 2013
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Purpose
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 | Intervention |
|---|---|
|
Obstructive Sleep Apnea |
Device: CPAP |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea |
Resource links provided by NLM:
Further study details as provided by University of Lisbon:
Primary Outcome Measures:
- Plasma nitrate (NOx) levels [ Time Frame: one month ] [ Designated as safety issue: No ]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:
- 24 h Blood pressure [ Time Frame: one month after CPAP ] [ Designated as safety issue: No ]Ambulatory BP were obtained at baseline and after 1 month of CPAP.
- Urinary norepinephrine (U-NE) levels [ Time Frame: One month ] [ Designated as safety issue: No ]After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.
| Enrollment: | 67 |
| Study Start Date: | July 2004 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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)
|
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.
Eligibility| Ages Eligible for Study: | 20 Years to 65 Years |
| Genders 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
Contacts and Locations More Information
No publications provided by University of Lisbon
Additional 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 |
| Study First Received: | November 17, 2012 |
| Last Updated: | January 16, 2013 |
| Health Authority: | Portugal: Ethics Committee for Clinical Research |
Keywords provided by 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 Disorders Nervous System Diseases Norepinephrine Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Vasoconstrictor Agents Cardiovascular Agents Therapeutic Uses Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013