AzTrials
AzTrials

Obstructive Sleep ApneaSTIFFSLEEPNCT02273089

CPAP to Reduce Arterial Stiffness in Non Sleepy, Moderate to Severe Obstructive Sleep Apnea (STIFFSLEEP)

An observational study of Obstructive Sleep Apnea and Vascular Stiffness, run by Centro Hospitalar de Lisboa Central at 2 sites in Portugal.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea . Read more about this study

Who is it for?
Ages 30 to 65 years, men only
What is being tested?
CPAP (ResMed S9 AutoSet)
Type of treatment
Medical device
How many people
45 participants
Where
2 sitesPortugal
Study dates
Oct 2012to Jun 2017
Phase
Observational
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 30 to 65 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Study population: Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness

Who may be able to join

  • moderate to severe obstructive sleep apnea, defined as apnea/hypopnea index superior to 15

Who cannot join

  • Epworth sleep scale superior to 16
  • other sleep diseases
  • moderate or severe lung disease
  • cardiac disease other than hypertension
  • cerebrovascular diseases
  • other vascular diseases
  • other chronic diseases except metabolic syndrome

Trial locations and contacts

2 sites in 1 country.

Portugal2 sites

  • Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central

    Lisbon, 1169-024

  • Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central

    Lisbon, 1169-024

Other trials in Portugal

About this study

Official title: Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)

This study intends to determine whether continuous positive airway pressure (CPAP) can reduce arterial stiffness (measured by pulse wave velocity) in nonsleepy as well as in sleepy patients with obstructive sleep apnea .

Read the detailed description

Obstructive sleep apnea (OSA) is associated with increased cardiovascular morbidity and mortality. Arterial stiffness, evaluated by pulse wave velocity, is related to atherosclerosis and cardiovascular risk. It has been reported that arterial stiffness is higher in patients with OSA than in healthy control groups, and it is assumed that it decreases after treatment with CPAP.

In patients with OSA without daytime hypersomnolence it is not clear if CPAP has some benefits on cardiovascular events and hypertension.

This study aims to evaluate the effect of CPAP therapy in an interventional cohort of patients with moderate to severe OSA, in which each patient will be is own control, for ethical reasons; the effect of CPAP therapy on the subcohorts of sleepy and of nonsleepy patients will be compared. The effect of a three months trial of CPAP will be assessed.

Being tested
CPAP (ResMed S9 AutoSet)
Keywords
Obstructive sleep apnea, arterial stiffness, CPAP, excessive daytime sleepiness, pulse wave velocity
Medical subject headings
Sleep Apnea, Obstructive, Disorders of Excessive Somnolence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP (ResMed S9 AutoSet)Device

    nocturnal CPAP for three months

Study groups in NCT02273089
Study groupRoleWhat they receive
OSA w/o EDSMales with moderate to severe obstructive sleep apnea without excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months
Receives: Device: CPAP (ResMed S9 AutoSet)
OSA w EDSMales with moderate to severe obstructive sleep apnea with excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months
Receives: Device: CPAP (ResMed S9 AutoSet)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Aortic pulse wave velocity (PWV)

    carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France).

    Measured: Change on PWV from baseline up to three months of intervention

Secondary outcomes (3)

  1. Apnea-Hypopnea Index (AHI)

    AHI is an index used to assess the severity of sleep apnea based on the total number of complete cessations (apnea) and partial obstructions (hypopnea) of breathing occurring per hour of sleep, using polygraphic study.

    Measured: Change on AHI from baseline up to three months of intervention

  2. Nocturnal oxygenation

    Measure of minimal saturation of oxygen (SO2), time under 90% SO2, average SO2, oxygen desaturation index, using polygraphic study.

    Measured: Change from baseline up to three months of intervention

  3. Excessive daytime sleepiness

    Epworth sleep scale (ESS)

    Measured: Change on ESS from baseline up to three months of intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2014 (estimated)
  2. Study startOct 2012
  3. Primary completionDec 2016
  4. Study completionJun 2017

Why it stopped: Recruitment stopped due to time restrains

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02273089
Sponsor's protocol ID
CHLC.CI.105.2014
Acronym
STIFFSLEEP
Status last verified
Jul 2017
First submitted
6 Oct 2014
Last updated
13 Jul 2017
Results posted
No
Data monitoring committee
No

Publications

  • Mineiro MA, Silva PMD, Alves M, Papoila AL, Marques Gomes MJ, Cardoso J. The role of sleepiness on arterial stiffness improvement after CPAP therapy in males with obstructive sleep apnea: a prospective cohort study. BMC Pulm Med. 2017 Dec 8;17(1):182. doi: 10.1186/s12890-017-0518-z.

    PubMed 29221483

  • Mineiro MA, Marques da Silva P, Alves M, Virella D, Marques Gomes MJ, Cardoso J. Use of CPAP to reduce arterial stiffness in moderate-to-severe obstructive sleep apnoea, without excessive daytime sleepiness (STIFFSLEEP): an observational cohort study protocol. BMJ Open. 2016 Jul 12;6(7):e011385. doi: 10.1136/bmjopen-2016-011385.

    PubMed 27406645

Questions about this trial

What is this clinical trial studying?

An observational study of Obstructive Sleep Apnea and Vascular Stiffness, run by Centro Hospitalar de Lisboa Central at 2 sites 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 7 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: stopped early, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 was stopped early (reason given: Recruitment stopped due to time restrains). Results are not available in the source record.

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?

Aortic pulse wave velocity (PWV) (time frame: Change on PWV from baseline up to three months of intervention). 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 NCT02273089, which also lists 2 linked publications.

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 13 Jul 2017; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in