Sleep Apnea Syndrome and Community Acquired Pneumonia (NEBULOSA)

Prevalence of Sleep Apnea-hypopnea Syndrome in Patients With Community Acquired Pneumonia, Prospective and Comparative Case-control Study

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.

Study Overview

• Status: Completed
• Conditions: Infections; Community Acquired Pneumonia; Sleep Apnea Syndrome; Polygraphy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 123

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • San Juan de Alicante, Alicante, Spain, 03550
      • Sección de Neumología. Hospital Universitario San Juan de Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	2 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospital Universitario San Juan de Alicante
• Investigators: Study Director: Eusebi Chiner, MD, Head of Pneumology Section; Principal Investigator: Mónica Llombart, MD, Consultant

Publications and helpful links

General Publications

• Chiner E, Llombart M, Valls J, Pastor E, Sancho-Chust JN, Andreu AL, Sanchez-de-la-Torre M, Barbe 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (ACTUAL): December 1, 2008
• Study Completion (ACTUAL): December 1, 2008

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (ESTIMATE): February 19, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): February 19, 2010
• Last Update Submitted That Met QC Criteria: February 18, 2010
• Last Verified: February 1, 2006

More Information

Terms related to this study

• Keywords: prevalence; community acquired pneumonia; Sleep apnea syndrome
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Lung Diseases; Disease; Signs and Symptoms, Respiratory; Sleep Apnea Syndromes; Syndrome; Apnea; Pneumonia
• Other Study ID Numbers: NEBULOSA PROJECT