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

Obstructive Sleep Apnea Clinical Trial

— STIFFSLEEP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02273089
• Other study ID #: CHLC.CI.105.2014
• Status: Terminated
• Phase: N/A
• First received: October 6, 2014
• Last updated: July 11, 2017
• Start date: October 2012
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Centro Hospitalar de Lisboa Central
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 .

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Parasomnias
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder Daytime Somnolence
• Sleep Wake Disorders
• Vascular Stiffness

Intervention

Device:
• CPAP (ResMed S9 AutoSet)
nocturnal CPAP for three months

Locations

Country	Name	City	State
Portugal	Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central	Lisboa
Portugal	Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central	Lisboa

Sponsors (2)

Lead Sponsor	Collaborator
Centro Hospitalar de Lisboa Central	Universidade Nova de Lisboa

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Lipidic profile	total serum cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides	Change from baseline up to three months of intervention
Other	Glucidic profile	fasting serum glucose and HbA1c	Change from baseline up to three months of intervention
Primary	Aortic pulse wave velocity (PWV)	carotid-femoral (aortic) pulse wave velocity (PWV) measured by noninvasive piezo-electronic system with Complior(R) (Colson, France).	Change on PWV from baseline up to three months of intervention
Secondary	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.	Change on AHI from baseline up to three months of intervention
Secondary	Nocturnal oxygenation	Measure of minimal saturation of oxygen (SO2), time under 90% SO2, average SO2, oxygen desaturation index, using polygraphic study.	Change from baseline up to three months of intervention
Secondary	Excessive daytime sleepiness	Epworth sleep scale (ESS)	Change on ESS from baseline up to three months of intervention