Clinical trial NCT01329159: Cardio-Respiratory Health and Indoor Pollution
Official title: Cardio-Respiratory Health in High Altitude Residents Exposed to Indoor Pollution
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Disease
Cardiovascular Disease
Keywords: High altitude
respiratory function
cardiorespiratory health
indoor pollution
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
First posted: 2011-04-05
Enrollment: 300
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: residents in the Kumbu Valley (Nepal)

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.


Eligibility criteria: Inclusion Criteria:

* residents in the villages of the valley

Exclusion Criteria:

* under the age of 14

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Department of Clinical and Experimental Medicine- section of Respiratory Disease-University of Ferrara
Study officials:
affiliation: University of Ferrara, Italy
name: Annalisa Cogo, MD
role: STUDY_DIRECTOR
affiliation: Institute of Clinical Physiology National Council of Research, Pisa, Italy
name: Lorenza Pratali, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Ferrara
name: Luca Pomidori, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kathmandu University
name: Sanjay Nath Khanal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi di Ferrara
name: Enrico Duo
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Clinical Physiology National Council of Research, Pisa, Italy
name: Maria Rosa Bruno, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tribhuvan University Institute of Medicine (Nepal)
name: Chan Bahadur Thapa, MD
role: PRINCIPAL_INVESTIGATOR
References: