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Recruitment stopped due to time restrains
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| Name | Class |
|---|---|
| Universidade Nova de Lisboa | OTHER |
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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 .
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CPAP (ResMed S9 AutoSet) | Device | nocturnal CPAP for three months |
|
| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Men with moderate to severe obstructive sleep apnea, with or without excessive daytime sleepiness
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| Name | Affiliation | Role |
|---|---|---|
| Alexandra Mineiro, MD | Centro Hospitalar de Lisboa Central | Principal Investigator |
| Pedro Marques-da-Silva, MD | Centro Hospitalar de Lisboa Central | Study Chair |
| João Cardoso, MD | Centro Hospitalar de Lisboa Central | Study Chair |
| Maria João Marques-Gomes, MD, PhD | Universidade Nova de Lisboa | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consulta de Sono, Departamento de Pneumologia, Centro Hospitalar de Lisboa Central | Lisbon | 1169-024 | Portugal | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29221483 | Derived | 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. | |
| 27406645 | Derived | 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. |
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| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| D006970 | Disorders of Excessive Somnolence |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
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| 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 |
| Change from baseline up to three months of intervention |
| Núcleo de Hipertensão Arterial, Consulta de Medicina do Hospital de Santa Marta, Centro Hospitalar de Lisboa Central |
| Lisbon |
| 1169-024 |
| Portugal |
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D001523 | Mental Disorders |
| D012138 |
| Respiratory Therapy |