HealthyNCT03408990
Confounding Factors of Impedance Pneumography
An observational study of Healthy and Sleep Apnea, run by Revenio Research at 1 site in Croatia.
Trial summary
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors… Read more about this study
- Who is it for?
- Ages 1 year to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Sleep Apnea
- How many people
- 20 participants
- Where
- 1 siteCroatia
- Study dates
- 26 Jan 2018to 27 Dec 2018
- 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 1 year to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects referred to sleep laboratory at the investigational site or healthy volunteers from Zagreb and surroundings
Who may be able to join
None listed.
Who cannot join
- Preterm birth with chronic respiratory disorder of prematurity
- Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
- Chronic rhinosinusitis, synonasal polyposis
- 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
- Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
Show all 11Show fewer
- Hospital-treated for bronchiolitis with residual symptoms
- Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
- Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
- Implanted or external active medical devices
- Long lasting respiratory events during the polysomnography study like continuous upper airway limitation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Confounding Factors of Impedance Pneumography Signal Changes During Sleep
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.
- Conditions
- Healthy, Sleep Apnea
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sleep study for clinical reasons | Children referred to sleep study for clinical reasons | |
| Healthy | Healthy children, no relevant pathologies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between sleep stages and tidal breathing flow-volume (TBFV) curves
Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep
Measured: 1 night
Secondary outcomes (1)
Association between body/head positions and tidal breathing flow-volume (TBFV) curves
Assess the correlation between Ventica-derived TBFV curves within and between different body/head positions (derived from video and/or positional sensors) during night sleep
Measured: 1 night
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2018
- Study start26 Jan 2018
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cross-sectional
- Enrolment
- 20 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
- NCT03408990
- Sponsor's protocol ID
- VCS-005
- Status last verified
- May 2019
- First submitted
- 16 Jan 2018
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confounding Factors of Impedance Pneumography Signal Changes During Sleep
- ClinicalTrials.gov ID
- NCT03408990
- Acronym / sponsor ID
- VCS-005
- Conditions
- Healthy, Sleep Apnea
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Revenio ResearchIndustry (pharma, biotech, devices)
- Collaborators
- Children's Hospital Srebrnjak
- Study start
- 26 Jan 2018 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 24 Jan 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.
The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep study for clinical reasons | – | –Children referred to sleep study for clinical reasons |
| Healthy | – | –Healthy children, no relevant pathologies |
Who may qualify
- Ages
- 1 year to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects referred to sleep laboratory at the investigational site or healthy volunteers from Zagreb and surroundings
Key inclusion criteria (0 listed)
Key exclusion criteria (11 listed)
- Preterm birth with chronic respiratory disorder of prematurity
- Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
- Chronic rhinosinusitis, synonasal polyposis
- 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
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
Association between sleep stages and tidal breathing flow-volume (TBFV) curves
Time frame: 1 night
Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep
1 secondary outcome
Association between body/head positions and tidal breathing flow-volume (TBFV) curves
Time frame: 1 night
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 21 May 2019.
- Individual participant dataSharing planned: No
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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 and Sleep Apnea, 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 0 inclusion and 11 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 21 May 2019. 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?
Association between sleep stages and tidal breathing flow-volume (TBFV) curves (time frame: 1 night). 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 21 May 2019.