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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02273089 |
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Date of registration:
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06/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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CPAP to Reduce Arterial Stiffness in Non Sleepy, Moderate to Severe Obstructive Sleep Apnea (STIFFSLEEP)
STIFFSLEEP |
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Scientific title:
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Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP) |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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45 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02273089 |
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Study type:
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Observational |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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Portugal
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Contacts
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Name:
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Alexandra Mineiro, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar de Lisboa Central |
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Name:
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João Cardoso, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar de Lisboa Central |
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Name:
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Pedro Marques-da-Silva, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centro Hospitalar de Lisboa Central |
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Name:
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Maria João Marques-Gomes, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Universidade Nova de Lisboa |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Vascular Stiffness
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Obstructive Sleep Apnea
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Sleep Disorder Daytime Somnolence
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Intervention(s)
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Device: CPAP (ResMed S9 AutoSet)
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Primary Outcome(s)
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Aortic pulse wave velocity (PWV)
[Time Frame: Change on PWV from baseline up to three months of intervention]
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Secondary Outcome(s)
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Apnea-Hypopnea Index (AHI)
[Time Frame: Change on AHI from baseline up to three months of intervention]
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Nocturnal oxygenation
[Time Frame: Change from baseline up to three months of intervention]
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Excessive daytime sleepiness
[Time Frame: Change on ESS from baseline up to three months of intervention]
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Secondary ID(s)
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CHLC.CI.105.2014
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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