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

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

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 .

Study Overview

• Status: Terminated
• Conditions: Obstructive Sleep Apnea; Vascular Stiffness; Sleep Disorder Daytime Somnolence
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Portugal
  • 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
    • Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Excessive daytime sleepiness	Epworth sleep scale (ESS)	Change on ESS from baseline up to three months of intervention

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centro Hospitalar de Lisboa Central
• Collaborators: Universidade Nova de Lisboa
• Investigators: 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 and helpful links

General Publications

• Mineiro MA, Silva PMD, Alves M, Papoila AL, Marques Gomes MJ, Cardoso J. The role of sleepiness on arterial stiffness improvement after CPAP therapy in males with obstructive sleep apnea: a prospective cohort study. BMC Pulm Med. 2017 Dec 8;17(1):182. doi: 10.1186/s12890-017-0518-z.
• Mineiro MA, Marques da Silva P, Alves M, Virella D, Marques Gomes MJ, Cardoso J. Use of CPAP to reduce arterial stiffness in moderate-to-severe obstructive sleep apnoea, without excessive daytime sleepiness (STIFFSLEEP): an observational cohort study protocol. BMJ Open. 2016 Jul 12;6(7):e011385. doi: 10.1136/bmjopen-2016-011385.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2012
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: October 6, 2014
• First Submitted That Met QC Criteria: October 21, 2014
• First Posted (Estimate): October 23, 2014

Study Record Updates

• Last Update Posted (Actual): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Obstructive sleep apnea; CPAP; excessive daytime sleepiness; pulse wave velocity; arterial stiffness
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Neurologic Manifestations; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Sleep Wake Disorders; Apnea; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: CHLC.CI.105.2014