Cardio-Respiratory Health and Indoor Pollution

NCT ID: NCT01329159

Last Updated: 2011-04-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2012-07-31

Brief Summary

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.

Conditions

Pulmonary Disease; Cardiovascular Disease

Study Design

• Observational Model Type: ECOLOGIC_OR_COMMUNITY
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

Inclusion Criteria

• residents in the villages of the valley

Exclusion Criteria

• under the age of 14

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

OTHER_GOV

Sponsor Role: collaborator

Università degli Studi di Ferrara

OTHER

Sponsor Role: lead

Responsible Party

University of Ferrara

Principal Investigators

Annalisa Cogo, MD

Role: STUDY_DIRECTOR

University of Ferrara, Italy

Lorenza Pratali, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Physiology National Council of Research, Pisa, Italy

Luca Pomidori, PhD

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Sanjay Nath Khanal, MD

Role: PRINCIPAL_INVESTIGATOR

Kathmandu University

Enrico Duo

Role: PRINCIPAL_INVESTIGATOR

Università degli Studi di Ferrara

Maria Rosa Bruno, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Clinical Physiology National Council of Research, Pisa, Italy

Chan Bahadur Thapa, MD

Role: PRINCIPAL_INVESTIGATOR

Tribhuvan University Institute of Medicine (Nepal)

Locations

Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara

Ferrara, Ferrara, Italy

Countries

Italy

Central Contacts

Annalisa Cogo, MD

Role: CONTACT

cga@unife.it

+390532210420

Facility Contacts

Annalisa Cogo, MD

Role: primary

cga@unife.it

+390532210420

Other Identifiers

HA indoor/pollution

Identifier Type: -

Identifier Source: org_study_id