Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01769807
Acronym
SABIO
Enrollment
67
Registered
2013-01-17
Start date
2004-07-31
Completion date
2008-12-31
Last updated
2013-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apnea, CPAP treatment, Plasma nitrate, Urinary norepinephrine, Blood pressure

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.

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.

Interventions

DEVICECPAP

CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.

Sponsors

University of Lisbon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Plasma nitrate (NOx) levelsone monthAfter 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

MeasureTime frameDescription
24 h Blood pressureone month after CPAPAmbulatory BP were obtained at baseline and after 1 month of CPAP.
Urinary norepinephrine (U-NE) levelsOne monthAfter sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026