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Swimming Pool Environment Impact on the Human Respiratory Health (SWAN)

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ClinicalTrials.gov Identifier: NCT03017976
Recruitment Status : Unknown
Verified October 2016 by Universidade do Porto.
Recruitment status was:  Not yet recruiting
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Universidade do Porto

Brief Summary:
This study aims to assess the influence of exposure to swimming pool environment on respiratory symptoms and diseases, and on cancer outcomes among swimmers and swimming pool attendants.

Condition or disease
Asthma Lung Disease Genotoxicity

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Swan Study: Swimming Pool Environment Impact on the Human Respiratory Health
Study Start Date : January 2017
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : July 2018

Group/Cohort
Competitive swimmers
Regular and naïf competitive swimmers will be followed for a mean period of 90 days. A battery of measurements and biological samples will be collected at the baseline evaluation and 90 days after, in order to evaluate long-term changes in respiratory health biomarkers. Measurements will also be performed before and after a single regular training session in order to assess acute effects in respiratory health biomarkers.
Recreational swimmers and swimming pool staff
Swimming pool physicochemical and microbiological characteristics and the association between each parameter measured as an indicator of water and air quality, contamination of surfaces will be evaluated and the association with recreational users, swimming teachers and pool attendants health parameters will be studied.



Primary Outcome Measures :
  1. Spirometry with bronchodilation [ Time Frame: First week after recruitment ]
  2. Airway resistance measurement [ Time Frame: First week after recruitment ]
  3. Airway reactance measurement [ Time Frame: First week after recruitment ]
  4. Fractional concentration of orally exhaled nitric oxide [ Time Frame: First week after recruitment ]
  5. Volatile organic compounds in the exhaled breath condensate [ Time Frame: First week after recruitment ]

Secondary Outcome Measures :
  1. Diagnosis of immunoglobulin E (IgE) mediated allergies by skin prick testing [ Time Frame: First week after recruitment ]
  2. Autonomic nervous system function assessment by pupillometry [ Time Frame: First week after recruitment ]
  3. Transepidermal water loss [ Time Frame: First week after recruitment ]

Biospecimen Retention:   Samples With DNA
Exhaled breath condensate (no DNA) Blood (DNA) Urine (DNA)


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Competitive swimmers, recreational users and swimming pool workers attending chlorinated and brominated public indoor municipal swimming pools in the North of Portugal.
Criteria
Competitive swimmers, recreational swimmers or pool workers of a participating indoor swimming pool; Individuals with 12 years of age or older; Individuals who provide (or their caregivers) a signed informed consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017976


Locations
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Portugal
Faculty of Medicine of Porto University
Porto, Portugal, 4200-319
Contact: André Moreira, MD, PhD    00351932730090    andremoreira@med.up.pt   
Contact: Vânia Mendes, MSc    00351918567504    vaniamendes@med.up.pt   
Principal Investigator: André Moreira, MD, PhD         
Sponsors and Collaborators
Universidade do Porto
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Responsible Party: Universidade do Porto
ClinicalTrials.gov Identifier: NCT03017976    
Other Study ID Numbers: NORTE-01-0145-FEDER-000010
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases