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

Primary Purpose

Obstructive Sleep Apnea

Status

Completed

Phase

Not Applicable

Locations

Portugal

Study Type

Interventional

Intervention

CPAP

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Sleep apnea, CPAP treatment, Plasma nitrate, Urinary norepinephrine, Blood pressure

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Hospital Pulido Valente

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CPAP treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

24 h Blood pressure

Ambulatory BP were obtained at baseline and after 1 month of CPAP.

Urinary norepinephrine (U-NE) levels

After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.

Full Information

NCT ID

NCT01769807

First Posted

November 17, 2012

Last Updated

January 16, 2013

Sponsor

University of Lisbon

1. Study Identification

Unique Protocol Identification Number

NCT01769807

Brief Title

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

Acronym

SABIO

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Completed

Study Start Date

July 2004 (undefined)

Primary Completion Date

December 2008 (Actual)

Study Completion Date

December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Lisbon

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obstructive Sleep Apnea

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

67 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPAP treatment

Arm Type

Experimental

Arm Description

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.

Intervention Type

Device

Intervention Name(s)

CPAP

Other Intervention Name(s)

Automated pressure setting device (AutoSet Spirit, ResMed)

Intervention Description

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

Primary Outcome Measure Information:

Title

Plasma nitrate (NOx) levels

Description

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.

Time Frame

one month

Secondary Outcome Measure Information:

Title

24 h Blood pressure

Description

Ambulatory BP were obtained at baseline and after 1 month of CPAP.

Time Frame

one month after CPAP

Title

Urinary norepinephrine (U-NE) levels

Description

After sleep apnea diagnosis, measurements of urinary norepinephrine levels were obtained at baseline and after 1 month of CPAP.

Time Frame

One month

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paula G Pinto, PhD

Organizational Affiliation

University of Lisbon

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Pulido Valente

City

Lisbon

ZIP/Postal Code

1769-001

Country

Portugal

12. IPD Sharing Statement

Citations:

PubMed Identifier

23497046

Citation

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.

Results Reference

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

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