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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01886339
Other study ID # 09/117/1031
Secondary ID
Status Completed
Phase N/A
First received June 21, 2013
Last updated March 17, 2017
Start date June 2010
Est. completion date June 2016

Study information

Verified date March 2017
Source Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

SNIF test has been described as a method to explore the diaphragmatic function. But there are no defined the reference values of this test in healthy population. The investigators' hypothesis is that there is a variation on SNIF values in Mediterranean population depending on gender, age and anthropometric variables such as height and weight.

The investigators will analyze 1000 SNIF test of healthy people. The investigators will divide in 5 groups of age (20-30, 30-40, 40-50, 50-60, 60-70) and in each group the investigators will study 100 men and 100 women.

All the subjects will perform a forced spirometry, maximal inspiratory pressure (MIP) and SNIF. If spirometry and MIP are correct the investigators will consider that person has a correct diaphragmatic function and strength. Then the investigators will measure the SNIF test. With all of these SNIF values the investigators will try to achieve the reference values of this test in the different groups of age in Mediterranean population. And the investigators will compare SNIF with MIP.

Cross multicentric study. Hospitals involved: Hospital de Bellvitge, Hospital del Mar, Hospital Parc Taulí, Hospital de la Santa Creu i Sant Pau (coordinator center) and Hospital de la Vall d'Hebrón.


Recruitment information / eligibility

Status Completed
Enrollment 439
Est. completion date June 2016
Est. primary completion date January 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria:

- Healthy people with spirometry and MIP values in the reference range

- Age between 20 and 70 years old

- Caucasian race

Exclusion Criteria:

- Rhinitis

- Nasal obstruction

- Frequent episodes of epistaxis

- Ongoing cold

Study Design


Related Conditions & MeSH terms


Intervention

Other:
SNIF test (Sniff Nasal Inspiratory Force)


Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary SNIF test Main objectives:
To define the SNIF reference values in a healthy Mediterranean population.
Analyze the influence of different variables such as gender, age, height and weight on this measure.
Basal
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