Sleep Apnea Syndrome and Community Acquired Pneumonia

NCT ID: NCT01071421

Last Updated: 2010-02-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 123 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2008-12-31

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 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

Conditions

Sleep Apnea Syndrome; Polygraphy; Community Acquired Pneumonia; Infections

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Control Group (B): Other Infections

Other infections admitted to the hospital

abbreviated polysomnography

Intervention Type: DEVICE

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

Community Acquired Pneumonia (Group A)

Patients admitted to hospital with Community Acquired Pneumonia defined by respiratory symptoms, fever and lung infiltrates

abbreviated polysomnography

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Respiratory Polygraphy; portable polysomnography

Eligibility Criteria

Inclusion Criteria

• Hospital admission and Community acquired pneumonia

• Hospital admission and other infections different to respiratory infections

Exclusion Criteria

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

Group B

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario San Juan de Alicante

OTHER

Sponsor Role: lead

Responsible Party

Hospital Universitario San Juan de Alicante

Principal Investigators

Eusebi Chiner, MD

Role: STUDY_DIRECTOR

Head of Pneumology Section

Mónica Llombart, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant

Locations

Sección de Neumología. Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, Alicante, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27050437 (View on PubMed)

Other Identifiers

NEBULOSA PROJECT

Identifier Type: -

Identifier Source: org_study_id