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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02273089

Acronym

STIFFSLEEP

Enrollment

Registered

2014-10-23

Start date

2012-10-31

Completion date

2017-06-30

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea, Sleep Disorder Daytime Somnolence, Vascular Stiffness

Keywords

Obstructive sleep apnea, arterial stiffness, CPAP, excessive daytime sleepiness, pulse wave velocity

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.

Interventions

DEVICECPAP (ResMed S9 AutoSet)

nocturnal CPAP for three months

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

30 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Other

Measure	Time frame	Description
Lipidic profile	Change from baseline up to three months of intervention	total serum cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides
Glucidic profile	Change from baseline up to three months of intervention	fasting serum glucose and HbA1c

Countries

Portugal

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026