Cardio-Respiratory Health and Indoor Pollution

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by Università degli Studi di Ferrara.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Information provided by:
Università degli Studi di Ferrara
ClinicalTrials.gov Identifier:
NCT01329159
First received: April 1, 2011
Last updated: April 4, 2011
Last verified: March 2011
  Purpose

The aim of this study is to assess in the sample of population resident in the KHUMBU valley (NEPAL):

  1. the respiratory function decline by means of spirometry and the respiratory health by means of questionnaire and six-minute walking distance
  2. the presence of markers of early atherosclerosis with ultrasound and to estimate the value of systolic pulmonary pressure in comparison with not exposed subjects.

The investigators hypothesize that the chronic exposure to indoor pollution

  1. can accelerate the physiological respiratory function decline, usually around 15-20mL/year in healthy subjects
  2. induce cardiovascular impairment

    The population of high altitude villages is a unique sample to study the effect of the only indoor pollution. In fact, the absence of traffic, due to the lack of roads, and the very low level of smoking habits allow to have no other confounding factors

  3. to study and analyze how the architectural features of the buildings of the village (distribution of domestic locals, natural or non natural ventilation systems, domestic activities, materials used, etc.) affect the indoor pollution from carbon monoxide, which necessarily is developed indoor during the daily life activities.

What the project prospects is to gather information focused on the scale of the building, independently from the typology, to study a model that will help to describe which aspects are most important to what concern the genesis of the pollution of the indoor air.


Condition
Pulmonary Disease
Cardiovascular Disease

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution

Further study details as provided by Università degli Studi di Ferrara:

Estimated Enrollment: 300
Study Start Date: April 2011
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   14 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

residents in the Kumbu Valley (Nepal)

Criteria

Inclusion Criteria:

  • residents in the villages of the valley

Exclusion Criteria:

  • under the age of 14
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329159

Contacts
Contact: Annalisa Cogo, MD +390532210420 cga@unife.it

Locations
Italy
Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara Not yet recruiting
Ferrara, Italy, 44100
Contact: Annalisa Cogo, MD    +390532210420    cga@unife.it   
Principal Investigator: Annalisa Cogo, MD         
Sponsors and Collaborators
Università degli Studi di Ferrara
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Investigators
Study Director: Annalisa Cogo, MD University of Ferrara, Italy
Principal Investigator: Lorenza Pratali, MD Institute of Clinical Physiology National Council of Research, Pisa, Italy
Principal Investigator: Luca Pomidori, PhD Università degli Studi di Ferrara
Principal Investigator: Sanjay Nath Khanal, MD Kathmandu University
Principal Investigator: Enrico Duo Università degli Studi di Ferrara
Principal Investigator: Maria Rosa Bruno, MD Institute of Clinical Physiology National Council of Research, Pisa, Italy
Principal Investigator: Chan Bahadur Thapa, MD Tribhuvan University Institute of Medicine (Nepal)
  More Information

No publications provided

Responsible Party: Annalisa Cogo, University of Ferrara
ClinicalTrials.gov Identifier: NCT01329159     History of Changes
Other Study ID Numbers: HA indoor/pollution
Study First Received: April 1, 2011
Last Updated: April 4, 2011
Health Authority: Nepal: Health Research Council

Keywords provided by Università degli Studi di Ferrara:
High altitude
respiratory function
cardiorespiratory health
indoor pollution

Additional relevant MeSH terms:
Cardiovascular Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014