Life ExperiencesValApPhINCT01881945
Validation of Study in Respiratory Physiology and it Interactions
A study testing Non-invasive physiological signal recording on healthy volunteer in people with Life Experiences and Respiratory Function, run by University Hospital, Grenoble at 1 site in France.
Trial summary
The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Life Experiences, Respiratory Function, Cardiac Function
- What is being tested?
- Non-invasive physiological signal recording on healthy volunteer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2008to Sep 2013
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy subject
- between 18 and 60 years old
Who cannot join
- patient
- person protected by the law
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Laboratoire TIMC-IMAG
La Tronche, 38700
Calabrese Pascale, PhD, 33456520060, Pascale.Calabrese@imag.fr
Briot Rapahel, MCU-PH
About this study
Official title: Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.
The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.
- Conditions
- Life Experiences, Respiratory Function, Cardiac Function
- Being tested
- Non-invasive physiological signal recording on healthy volunteer
- Keywords
- Swallowing, Hyperventilation
- Medical subject headings
- Respiratory Aspiration, Hyperventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive physiological signal recording on healthy volunteerOther
| Study group | Role | What they receive |
|---|---|---|
| Physiological measurments | Experimental | Not described Receives: Other: Non-invasive physiological signal recording on healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate
Heart rate is calculated on electrocardiograph
Measured: one measure within two weeks of inclusion
end tidal CO2
end tidal CO2 of each breath measured with an infrared CO2 analyzer
Measured: one measure within two weeks of inclusion
Non invasive arterial pressure
Measured: one measure within two weeks of inclusion
Non invasive stroke volume
measured with impedance cardiography
Measured: one measure within two weeks of inclusion
Inspiratory and expiratory times
obtained for each breath with flow signal
Measured: one measure within two weeks of inclusion
Tidal volume
obtained for each breath with flow signal
Measured: one measure within two weeks of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2013 (estimated)
- Study startSep 2008
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Life ExperiencesStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BRIOT Raphael, MCU-PH, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01881945
- Sponsor's protocol ID
- 2008-A00273-52
- Acronym
- ValApPhI
- Status last verified
- Jun 2013
- First submitted
- 24 May 2013
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Besleaga T, Blum M, Briot R, Vovc V, Moldovanu I, Calabrese P. Individuality of breathing during volitional moderate hyperventilation. Eur J Appl Physiol. 2016 Jan;116(1):217-25. doi: 10.1007/s00421-015-3260-3. Epub 2015 Sep 23.
PubMed 26400417
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Tools Studying Respiratory Physiology and it Interaction With Swallowing and Cardiac Physiology.
- ClinicalTrials.gov ID
- NCT01881945
- Acronym / sponsor ID
- ValApPhI / 2008-A00273-52
- Conditions
- Life Experiences, Respiratory Function, Cardiac Function
- Keywords
- Swallowing, Hyperventilation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 20 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.
The aim of the study was to validate tools of physiological signal processing and interpretation on healthy human volunteers in order to improve the understanding in respiratory physiology and its interactions with heart function, and swallowing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physiological measurments | Experimental | Other: Non-invasive physiological signal recording on healthy volunteer |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- healthy subject
- between 18 and 60 years old
Key exclusion criteria (2 listed)
- patient
- person protected by the law
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 |
|---|---|---|
| Non-invasive physiological signal recording on healthy volunteer | Other | Physiological measurments |
Primary outcome
Heart rate
Time frame: one measure within two weeks of inclusion
Heart rate is calculated on electrocardiograph
end tidal CO2
Time frame: one measure within two weeks of inclusion
end tidal CO2 of each breath measured with an infrared CO2 analyzer
Non invasive arterial pressure
Time frame: one measure within two weeks of inclusion
Non invasive stroke volume
Time frame: one measure within two weeks of inclusion
measured with impedance cardiography
Inspiratory and expiratory times
Time frame: one measure within two weeks of inclusion
obtained for each breath with flow signal
Tidal volume
Time frame: one measure within two weeks of inclusion
obtained for each breath with flow signal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
- Derived from this study: PubMed 26400417Besleaga T, Blum M, Briot R, Vovc V, Moldovanu I, Calabrese P. Individuality of breathing during volitional moderate hyperventilation. Eur J Appl Physiol. 2016 Jan;116(1):217-25. doi: 10.1007/s00421-015-3260-3. Epub 2015 Sep 23.
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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.
BRIOT Raphael, MCU-PH principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive physiological signal recording on healthy volunteer in people with Life Experiences and Respiratory Function, run by University Hospital, Grenoble at 1 site in France.
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 2 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 20 Jun 2013. 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 France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BRIOT Raphael, MCU-PH (33 4 76 63 42 86, RBriot@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate (time frame: one measure within two weeks of inclusion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01881945, which also lists 1 linked publication.
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 Jun 2013.