Ignite Creation Date:
2024-05-05 @ 10:17 PM
Last Modification Date:
2024-10-26 @ 10:16 AM
Study NCT ID:
NCT01071421
Status:
COMPLETED
Last Update Posted:
2010-02-19
First Post:
2010-02-18
Brief Title:
Sleep Apnea Syndrome and Community Acquired Pneumonia
Sponsor:
Hospital Universitario San Juan de Alicante
Organization:
Hospital Universitario San Juan de Alicante
Study Overview
Official Title:
Prevalence of Sleep Apnea-hypopnea Syndrome in Patients With Community Acquired Pneumonia Prospective and Comparative Case-control Study
Status:
COMPLETED
Status Verified Date:
2006-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEBULOSA
Brief Summary:
The association of sleep apnea-hypopnea syndrome SAHS with the infections of the lower airway has not been studied The aspiration of secretions of the upper airway and the colonization by microorganisms is considered a main event in most of the cases of community acquired pneumonia CAP and specially in the nosocomial pneumonia The silent aspiration to the lower airway is a common phenomenon in normal subjects during the sleep and some studies has reported that the patients with SAHS present an increase of the risk to pharyngeal aspirations In fact the presence of nasal and bronchial inflammation in patients with SAHS is a recognized event The patients with SAHS could have a risk increased to develop pneumonia due to predisposition to the pharyngeal microaspiration to lower airways during the sleep and other mechanical factors associated The prevalence of SAHS in patients with CAP could be increased as regards the data published for the same Spanish population The presence of an apnea-hypopnea index AHI could be a risk factor not only to to CAP but to to present a unfavorable clinical evolution in comparison to patients with CAP with a normal AHI The aim of this study will establish a relation between SAHS and the pneumonia risk
Detailed Description:
This is a prospective comparative case control study to compare the prevalence of sleep apnea-hypopnea syndrome in patients with community acquired pneumonia CAP
Patients hospitalized with CAP Group Awill be studied with respiratory polygraphy during the sleep and a second respiratory polygraphy will be conducted in home after the curation of the pneumonia one month During the admission etiological study including blood cultures serology urinary antigens for legionella and S pneumoniae sputum cultures and other invasive techniques as bronchoscopy when appropriate will be obtained Questionnaires related with sleep apnea-hypopnea syndrome will be obtained consisting in Epworth test symptoms questionnaires and FOSQ test
Group B are patients with other infections as urinary bone pelvic infections excluding upper or lower respiratory infections Respiratory polygraphy will be performed in this group as in the group A obtaining the same questionnaires
We compare the variables of respiratory polygraphy questionnaires scores percentage of patients with an AHI 12 between both groups and we compare the variables obtained in the respiratory polygraphy performed in hospital and at home in the group A to evaluate if the condition of an altered AHI was previous to the CAP episode We will obtain the prevalence of sleep apnea-hypopnea patients in both groups and we compare factor risks COPD diabetes mellitus bronchial asthma etc between A and B Finally multivariable analysis is conducted to evaluate the contribution of the AHI to CAP as other recognize factor risk
Both groups are paired by age sex and body mass index
Patients hospitalized with CAP Group Awill be studied with respiratory polygraphy during the sleep and a second respiratory polygraphy will be conducted in home after the curation of the pneumonia one month During the admission etiological study including blood cultures serology urinary antigens for legionella and S pneumoniae sputum cultures and other invasive techniques as bronchoscopy when appropriate will be obtained Questionnaires related with sleep apnea-hypopnea syndrome will be obtained consisting in Epworth test symptoms questionnaires and FOSQ test
Group B are patients with other infections as urinary bone pelvic infections excluding upper or lower respiratory infections Respiratory polygraphy will be performed in this group as in the group A obtaining the same questionnaires
We compare the variables of respiratory polygraphy questionnaires scores percentage of patients with an AHI 12 between both groups and we compare the variables obtained in the respiratory polygraphy performed in hospital and at home in the group A to evaluate if the condition of an altered AHI was previous to the CAP episode We will obtain the prevalence of sleep apnea-hypopnea patients in both groups and we compare factor risks COPD diabetes mellitus bronchial asthma etc between A and B Finally multivariable analysis is conducted to evaluate the contribution of the AHI to CAP as other recognize factor risk
Both groups are paired by age sex and body mass index
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None