Healthy People ProgramsSNIF REF VNCT01886339
SNIF (Sniff Nasal Inspiratory Force) Reference Values Of Mediterranean Population
An observational study of Healthy People Programs, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy People Programs
- What is being tested?
- SNIF test (Sniff Nasal Inspiratory Force)
- How many people
- 439 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community sample
Who may be able to join
- Healthy people with spirometry and MIP values in the reference range
- Age between 20 and 70 years old
- Caucasian race
Who cannot join
- Rhinitis
- Nasal obstruction
- Frequent episodes of epistaxis
- Ongoing cold
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SNIF (Sniff Nasal Inspiratory Force) REFERENCE VALUES OF MEDITERRANEAN POPULATION.
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.
Read more
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.
- Conditions
- Healthy People Programs
- Being tested
- SNIF test (Sniff Nasal Inspiratory Force)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SNIF test (Sniff Nasal Inspiratory Force)Other
| Study group | Role | What they receive |
|---|---|---|
| Healthy population | Not described Receives: Other: SNIF test (Sniff Nasal Inspiratory Force) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Basal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study startJun 2010
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy People ProgramsStudies of the same condition, open and under way.
- More trials run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886339
- Sponsor's protocol ID
- 09/117/1031
- Acronym
- SNIF REF V
- Status last verified
- Mar 2017
- First submitted
- 21 Jun 2013
- Last updated
- 20 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SNIF (Sniff Nasal Inspiratory Force) REFERENCE VALUES OF MEDITERRANEAN POPULATION.
- ClinicalTrials.gov ID
- NCT01886339
- Acronym / sponsor ID
- SNIF REF V / 09/117/1031
- Conditions
- Healthy People Programs
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy population | – | Other: SNIF test (Sniff Nasal Inspiratory Force) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample
Key inclusion criteria (3 listed)
- Healthy people with spirometry and MIP values in the reference range
- Age between 20 and 70 years old
- Caucasian race
Key exclusion criteria (4 listed)
- Rhinitis
- Nasal obstruction
- Frequent episodes of epistaxis
- Ongoing cold
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SNIF test (Sniff Nasal Inspiratory Force) | Other | Healthy population |
Primary outcome
SNIF test
Time frame: Basal
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy People Programs, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SNIF test (time frame: Basal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2017.