Sleep Apnea Syndrome and Community Acquired Pneumonia (NEBULOSA)

• ClinicalTrials.gov Identifier: NCT01071421
• Recruitment Status: Completed
• First Posted: February 19, 2010
• Last Update Posted: February 19, 2010
• Sponsor: Hospital Universitario San Juan de Alicante
• Information provided by: Hospital Universitario San Juan de Alicante

Study Description

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.

Condition or disease	Intervention/treatment
Sleep Apnea Syndrome; Polygraphy; Community Acquired Pneumonia; Infections	Device: abbreviated polysomnography

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 A)will 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 Design

• Study Type: Observational
• Actual Enrollment: 123 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Prevalence of Sleep Apnea-hypopnea Syndrome in Patients With Community Acquired Pneumonia, Prospective and Comparative Case-control Study
• Study Start Date: April 2006
• Actual Primary Completion Date: December 2008
• Actual Study Completion Date: December 2008

Groups and Cohorts

Group/Cohort	Intervention/treatment
Control Group (B): Other Infections; Other infections admitted to the hospital	Device: abbreviated polysomnography; Both groups will be studied with in-hospital respiratory polygraphy during the sleep. The group A will be studied with another respiratory polygraphy in the home one month after the resolution of CAP. Some questionnaires to measure the sleepiness (Epworth test), FOSQ test, in-home sleepiness questionnaire and symptoms questionary will be obtained in Group A and B; Other Names: Respiratory Polygraphy; portable polysomnography
Community Acquired Pneumonia (Group A); Patients admitted to hospital with Community Acquired Pneumonia defined by respiratory symptoms, fever and lung infiltrates	Device: abbreviated polysomnography; Both groups will be studied with in-hospital respiratory polygraphy during the sleep. The group A will be studied with another respiratory polygraphy in the home one month after the resolution of CAP. Some questionnaires to measure the sleepiness (Epworth test), FOSQ test, in-home sleepiness questionnaire and symptoms questionary will be obtained in Group A and B; Other Names: Respiratory Polygraphy; portable polysomnography

Outcome Measures

Primary Outcome Measures :

1. To evaluate the prevalence of sleep anea-hypopnea syndrome in patients with community acquired pneumonia, defined by an apnea-hypopnea index more to 12 measured by respiratory polygraphy [ Time Frame: 2 years ]

Secondary Outcome Measures :

1. To evaluate if the apnea-hypopnea index is a factor risk to community acquired pneumonia [ Time Frame: 2 years ]
2. To evaluate if a high apnea-hypopnea index is observed in patients with community acquired pneumonia and if is maintained after the pneumonia resolution [ Time Frame: 2 years ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to hospital with the diagnosis of community acquired pneumonia, excluding nosocomial pneumonia compared to patients with other infections excluding respiratory infections, admitted to hospital, paired by age, sex and body mass index

Criteria

Group A:

Inclusion Criteria:

• Hospital admission and Community acquired pneumonia

Exclusion Criteria:

• Nosocomial infections
• Low level of conscientiousness
• Neurological disease
• Impossibility to complete the questionnaires

Group B

Inclusion Criteria:

• Hospital admission and other infections different to respiratory infections

Contacts and Locations

Locations

Spain

Sección de Neumología. Hospital Universitario San Juan de Alicante

San Juan de Alicante, Alicante, Spain, 03550

Sponsors and Collaborators

Hospital Universitario San Juan de Alicante

Investigators

• Study Director: Eusebi Chiner, MD; Head of Pneumology Section
• Principal Investigator: Mónica Llombart, MD; Consultant

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chiner E, Llombart M, Valls J, Pastor E, Sancho-Chust JN, Andreu AL, Sánchez-de-la-Torre M, Barbé F. Association between Obstructive Sleep Apnea and Community-Acquired Pneumonia. PLoS One. 2016 Apr 6;11(4):e0152749. doi: 10.1371/journal.pone.0152749. eCollection 2016.

• Responsible Party: Eusebi Chiner/ Pneumology Chairman Hospital Universitario San Juan de Alicante, Hospital Universitario San Juan de Alicante
• ClinicalTrials.gov Identifier: NCT01071421
• Other Study ID Numbers: NEBULOSA PROJECT
• First Posted: February 19, 2010
• Last Update Posted: February 19, 2010
• Last Verified: February 2006

Keywords provided by Hospital Universitario San Juan de Alicante:

Sleep apnea syndrome; community acquired pneumonia; prevalence

Additional relevant MeSH terms:

Apnea; Sleep Apnea Syndromes; Pneumonia; Syndrome; Disease; Pathologic Processes; Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Lung Diseases; Respiratory Tract Infections