Healthy SubjectsNCT03551236
Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
An observational study of Healthy Subjects, run by Revenio Research at 1 site in Croatia.
Trial summary
This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthy Subjects
- How many people
- 40 participants
- Where
- 1 siteCroatia
- Study dates
- 17 Jan 2017to 3 Jul 2017
- 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 Any age
- Child, Adult, Older adult
Study population: Young children screened to have small probability of asthma or wheezing
Who may be able to join
- 18 months-6 years, both sexes
- Healthy at the time of inclusion
- Laboratory analyses in the reference range or not clinically relevant according to the investigator judgement
- Lung function in the reference range with a negative bronchodilator test result
- Signed informed consent
Who cannot join
- Preterm birth
- Chronic respiratory disorder of prematurity
- Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
- Primary immunodeficiency
- Chronic rhinosinusitis, synonasal polyposis
- Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing
Show all 10Show fewer
- Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
- Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
- Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion
- Implanted or external active medical devices such as pacemakers
Trial locations and contacts
1 site in 1 country.
About this study
This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic factors on the Ventica results.
- Conditions
- Healthy Subjects
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)
Analyse the normal range of variables that describe the shape and variability of tidal breathing flow-volume curves during natural night sleep obtained with impedance pneumography
Measured: 1-3 nights per subject
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2018
- Study start17 Jan 2017
- Primary completion3 Jul 2017
- Study completion3 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Revenio Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Srebrnjak
- Responsible party
- Sponsor
- Investigators
- Davor Plavec, MD, PhD, Principal investigator, Children's Hospital Srebrnjak
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03551236
- Sponsor's protocol ID
- VCS-001
- Status last verified
- May 2018
- First submitted
- 28 May 2018
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
- ClinicalTrials.gov ID
- NCT03551236
- Acronym / sponsor ID
- VCS-001
- Conditions
- Healthy Subjects
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Revenio ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Srebrnjak
- Study start
- 17 Jan 2017 (actual)
- Primary completion
- 3 Jul 2017 (actual)
- Study completion
- 3 Jul 2017 (actual)
- First posted
- 11 Jun 2018 (actual)
- 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.
This is an observational study for the assessment of normal overnight variation in small healthy children using the Ventica Lung Function Testing System. The study is carried out to establish reference ranges for overnight lung function variation using the Ventica test, and to assess the impact of the demographic factors on the Ventica results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Age groups
- Child, Adult, Older adult
- Study population
- Young children screened to have small probability of asthma or wheezing
Key inclusion criteria (5 listed)
- 18 months-6 years, both sexes
- Healthy at the time of inclusion
- Laboratory analyses in the reference range or not clinically relevant according to the investigator judgement
- Lung function in the reference range with a negative bronchodilator test result
- Signed informed consent
Key exclusion criteria (10 listed)
- Preterm birth
- Chronic respiratory disorder of prematurity
- Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
- Primary immunodeficiency
- Chronic rhinosinusitis, synonasal polyposis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)
Time frame: 1-3 nights per subject
Analyse the normal range of variables that describe the shape and variability of tidal breathing flow-volume curves during natural night sleep obtained with impedance pneumography
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 11 Jun 2018.
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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.
Davor Plavec, MD, PhD principal investigator
Children's Hospital Srebrnjak
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 Subjects, run by Revenio Research at 1 site in Croatia.
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 5 inclusion and 10 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 11 Jun 2018. 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 Croatia. 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?
Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.) (time frame: 1-3 nights per subject). 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 11 Jun 2018.