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

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ClinicalTrials.gov Identifier: NCT02273089
Recruitment Status : Terminated (Recruitment stopped due to time restrains)
First Posted : October 23, 2014
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Universidade Nova de Lisboa
Information provided by (Responsible Party):
Centro Hospitalar de Lisboa Central

Brief 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 .

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Vascular Stiffness Sleep Disorder Daytime Somnolence Device: CPAP (ResMed S9 AutoSet)

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.

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Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)
Actual Study Start Date : October 2012
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
OSA w/o EDS
Males with moderate to severe obstructive sleep apnea without excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months
Device: CPAP (ResMed S9 AutoSet)
nocturnal CPAP for three months

OSA w EDS
Males with moderate to severe obstructive sleep apnea with excessive daytime sleepiness will be proposed nocturnal CPAP (ResMed S9 AutoSet) for three months
Device: CPAP (ResMed S9 AutoSet)
nocturnal CPAP for three months




Primary Outcome Measures :
  1. Aortic pulse wave velocity (PWV) [ Time Frame: Change on PWV from baseline up to three months of intervention ]
    carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France).


Secondary Outcome Measures :
  1. Apnea-Hypopnea Index (AHI) [ Time Frame: Change on AHI from baseline up to three months of intervention ]
    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.

  2. Nocturnal oxygenation [ Time Frame: Change from baseline up to three months of intervention ]
    Measure of minimal saturation of oxygen (SO2), time under 90% SO2, average SO2, oxygen desaturation index, using polygraphic study.

  3. Excessive daytime sleepiness [ Time Frame: Change on ESS from baseline up to three months of intervention ]
    Epworth sleep scale (ESS)


Other Outcome Measures:
  1. Lipidic profile [ Time Frame: Change from baseline up to three months of intervention ]
    total serum cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides

  2. Glucidic profile [ Time Frame: Change from baseline up to three months of intervention ]
    fasting serum glucose and HbA1c



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273089


Locations
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Portugal
Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1169-024
Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central
Lisboa, Portugal, 1169-024
Sponsors and Collaborators
Centro Hospitalar de Lisboa Central
Universidade Nova de Lisboa
Investigators
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Principal Investigator: Alexandra Mineiro, MD Centro Hospitalar de Lisboa Central
Study Chair: Pedro Marques-da-Silva, MD Centro Hospitalar de Lisboa Central
Study Chair: João Cardoso, MD Centro Hospitalar de Lisboa Central
Study Director: Maria João Marques-Gomes, MD, PhD Universidade Nova de Lisboa

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centro Hospitalar de Lisboa Central
ClinicalTrials.gov Identifier: NCT02273089    
Other Study ID Numbers: CHLC.CI.105.2014
First Posted: October 23, 2014    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017
Keywords provided by Centro Hospitalar de Lisboa Central:
Obstructive sleep apnea
arterial stiffness
CPAP
excessive daytime sleepiness
pulse wave velocity
Additional relevant MeSH terms:
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Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Sleep Wake Disorders
Sleepiness
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Neurologic Manifestations
Mental Disorders