Obstructive Sleep ApneaSABIONCT01769807
Efficacy Study of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea (SABIO)
A study testing CPAP in people with Obstructive Sleep Apnea, run by University of Lisbon at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 years, men only
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 sitePortugal
- Study dates
- Jul 2004to Dec 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of obstructive sleep apnea
Who cannot join
- current smoker
- respiratory disease
- cardiac disease (except for arterial hypertension)
- renal disorder
- hepatic disorder
- psychiatric disorder
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea
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.
Read the 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.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP
- Keywords
- Sleep apnea, CPAP treatment, Plasma nitrate, Urinary norepinephrine, Blood pressure
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Also called Automated pressure setting device (AutoSet Spirit, ResMed)
CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
| Study group | Role | What they receive |
|---|---|---|
| CPAP treatment | Experimental | 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. Receives: Device: CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one month
Secondary outcomes (2)
24 h Blood pressure
Ambulatory BP were obtained at baseline and after 1 month of CPAP.
Measured: one month after 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.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2013 (estimated)
- Study startJul 2004
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lisbon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paula Pinto, University of Lisbon
- Investigators
- Paula G Pinto, PhD, Principal investigator, University of Lisbon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01769807
- Sponsor's protocol ID
- CEDOC
- Other IDs
- Fundação Ciência e Tecnologia
- Acronym
- SABIO
- Status last verified
- Jan 2013
- First submitted
- 17 Nov 2012
- Last updated
- 17 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23497046
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of CPAP on Nitrate and Norepinephrine Levels in Severe and Mild-moderate Sleep Apnea
- ClinicalTrials.gov ID
- NCT01769807
- Acronym / sponsor ID
- SABIO / CEDOC
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Sleep apnea, CPAP treatment, Plasma nitrate, Urinary norepinephrine, Blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of LisbonUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 17 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CPAP treatment | Experimental | Device: CPAP67 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. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of obstructive sleep apnea
Key exclusion criteria (20 listed)
- current smoker
- respiratory disease
- cardiac disease (except for arterial hypertension)
- renal disorder
- hepatic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CPAPAlso: Automated pressure setting device (AutoSet Spirit, ResMed)CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month. | Device | CPAP treatment |
Primary outcome
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.
2 secondary outcomes
24 h Blood pressure
Time frame: one month after CPAP
Urinary norepinephrine (U-NE) levels
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2013.
- Derived from this study: PubMed 23497046Pinto 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paula G Pinto, PhD principal investigator
University of Lisbon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP in people with Obstructive Sleep Apnea, run by University of Lisbon at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma nitrate (NOx) levels (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01769807, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2013.