Sleep Apnea Syndrome and Community Acquired Pneumonia

NCT01071421 | Completed DMC

• 1 other identifier: NEBULOSA PROJECT
• Study Type: observational
• Target: 123
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndrome; Polygraphy; Community Acquired Pneumonia; Infections

Keywords

Sleep apnea syndrome; community acquired pneumonia; prevalence

Outcome Measures

Primary Outcomes (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

  2 years

Secondary Outcomes (2)

• 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

Study Arms (2)

Control Group (B): Other Infections

Other infections admitted to the hospital

Device: abbreviated 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

Interventions

abbreviated polysomnography 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

Also known as: Respiratory Polygraphy, portable polysomnography

Community Acquired Pneumonia (Group A); Control Group (B): Other Infections

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Hospital admission and Community acquired pneumonia

You may not qualify if:

• Nosocomial infections
• Low level of conscientiousness
• Neurological disease
• Impossibility to complete the questionnaires
• Group B
• Hospital admission and other infections different to respiratory infections

Sponsors & Collaborators

• Hospital Universitario San Juan de Alicante: lead

Study Sites (1)

Sección de Neumología. Hospital Universitario San Juan de Alicante

Sant Joan d'Alacant, Alicante, 03550, Spain

Location

Related Publications (1)

• 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.

  PMID: 27050437 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes; Community-Acquired Pneumonia; Infections

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Community-Acquired Infections; Pneumonia; Respiratory Tract Infections

Study Officials

• Eusebi Chiner, MD

  Head of Pneumology Section

  STUDY DIRECTOR

• Mónica Llombart, MD

  Consultant

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 18, 2010
• First Posted: February 19, 2010
• Study Start: April 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: December 1, 2008
• Last Updated: February 19, 2010

Record last verified: 2006-02

Locations

ES (1)