NCT01886339

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
439

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

June 21, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

March 20, 2017

Status Verified

March 1, 2017

Enrollment Period

5.6 years

First QC Date

June 21, 2013

Last Update Submit

March 17, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Healthy population

Other: SNIF test (Sniff Nasal Inspiratory Force)

Interventions

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Community sample

You may qualify if:

  • Healthy people with spirometry and MIP values in the reference range
  • Age between 20 and 70 years old
  • Caucasian race

You may not qualify if:

  • Rhinitis
  • Nasal obstruction
  • Frequent episodes of epistaxis
  • Ongoing cold

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2013

First Posted

June 25, 2013

Study Start

June 1, 2010

Primary Completion

January 1, 2016

Study Completion

June 1, 2016

Last Updated

March 20, 2017

Record last verified: 2017-03

Locations