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

Terminated

• Conditions: Obstructive Sleep Apnea; Sleep Disorder Daytime Somnolence; Vascular Stiffness
• Interventions: Device: CPAP (ResMed S9 AutoSet)

• Registration Number: NCT02273089
• Lead Sponsor: 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 .

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2014-10-06
• Study First Submitted QC: 2014-10-21
• Study First Posted: 2014-10-23
• Primary Completion: 2016-12
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-11
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 45

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Aortic pulse wave velocity (PWV)	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

Name	Time	Method
Apnea-Hypopnea Index (AHI)	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.
Nocturnal oxygenation	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.
Excessive daytime sleepiness	Change on ESS from baseline up to three months of intervention	Epworth sleep scale (ESS)

Trial Locations

Locations (2)

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, Portugal