Trial record 9 of 1556 for:    Pneumonitis

Sleep Apnea Syndrome and Community Acquired Pneumonia (NEBULOSA)

This study has been completed.
Sponsor:
Information provided by:
Hospital Universitario San Juan de Alicante
ClinicalTrials.gov Identifier:
NCT01071421
First received: February 18, 2010
Last updated: NA
Last verified: February 2006
History: No changes posted
  Purpose

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 Intervention
Sleep Apnea Syndrome
Polygraphy
Community Acquired Pneumonia
Infections
Device: abbreviated polysomnography

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitario San Juan de Alicante:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate if the apnea-hypopnea index is a factor risk to community acquired pneumonia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 123
Study Start Date: April 2006
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
  • 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
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
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071421

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

No publications provided

Responsible Party: Eusebi Chiner/ Pneumology Chairman Hospital Universitario San Juan de Alicante, Hospital Universitario San Juan de Alicante
ClinicalTrials.gov Identifier: NCT01071421     History of Changes
Other Study ID Numbers: NEBULOSA PROJECT
Study First Received: February 18, 2010
Last Updated: February 18, 2010
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by Hospital Universitario San Juan de Alicante:
Sleep apnea syndrome
community acquired pneumonia
prevalence

Additional relevant MeSH terms:
Pneumonia
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Lung Diseases
Respiratory Tract Infections
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014