Clinical trial NCT02273089: CPAP to Reduce Arterial Stiffness in Non Sleepy, Moderate to Severe Obstructive Sleep Apnea (STIFFSLEEP)
Official title: Use of CPAP to Reduce Arterial Stiffness in Moderate to Severe Obstructive Sleep Apnea, Without Excessive Daytime Sleepiness (STIFFSLEEP)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstructive Sleep Apnea
Vascular Stiffness
Sleep Disorder Daytime Somnolence
Keywords: Obstructive sleep apnea
arterial stiffness
CPAP
excessive daytime sleepiness
pulse wave velocity
Lead sponsor: Centro Hospitalar de Lisboa Central
Sponsor class: OTHER
Collaborators: name: Universidade Nova de Lisboa
First posted: 2014-10-23
Enrollment: 45
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aortic pulse wave velocity (PWV)
timeFrame: Change on PWV from baseline up to three months of intervention
Secondary outcomes:
measure: Apnea-Hypopnea Index (AHI)
timeFrame: Change on AHI from baseline up to three months of intervention
measure: Nocturnal oxygenation
timeFrame: Change from baseline up to three months of intervention
measure: Excessive daytime sleepiness
timeFrame: Change on ESS from baseline up to three months of intervention
Other outcomes:
measure: Lipidic profile
timeFrame: Change from baseline up to three months of intervention
measure: Glucidic profile
timeFrame: Change from baseline up to three months of intervention
Locations:
city: Lisboa
country: Portugal
facility: Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central
city: Lisboa
country: Portugal
facility: Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central
Study officials:
affiliation: Centro Hospitalar de Lisboa Central
name: Alexandra Mineiro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centro Hospitalar de Lisboa Central
name: Pedro Marques-da-Silva, MD
role: STUDY_CHAIR
affiliation: Centro Hospitalar de Lisboa Central
name: João Cardoso, MD
role: STUDY_CHAIR
affiliation: Universidade Nova de Lisboa
name: Maria João Marques-Gomes, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.