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CompletedNCT03408990Updated May 21, 2019

Confounding Factors of Impedance Pneumography

An observational study in Healthy and Sleep Apnea, sponsored by Revenio Research. Completed at 1 site in Croatia. Open to participants aged 1 Year to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-21.

Sponsored by Revenio Research · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
20
Ages
1 Year to 7 Years
Sex
All
01

Study 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 for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.

02

Conditions studied

  • Healthy
  • Sleep Apnea
03

Who can participate

Ages eligible
1 Year to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Subjects referred to sleep laboratory at the investigational site or healthy volunteers from Zagreb and surroundings

Eligibility criteria

Group 1: (children referred to sleep study for clinical reasons) Inclusion criteria:

  • Age 1-7 years, both sexes
  • Referred to polysomnography
  • Signed informed consent

Group 2: (healthy children) Inclusion criteria:

  • 2-7 years, both sexes
  • Healthy at the time of inclusion based on history and clinical examination according to the investigator judgement
  • Lung function in the reference range
  • Signed informed consent

Exclusion Criteria:

  • 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)
  • 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
04

Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
20 participants (actual)
Patient registry
No

Groups and cohorts

  • Sleep study for clinical reasons

    Children referred to sleep study for clinical reasons

  • Healthy

    Healthy children, no relevant pathologies

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 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

    Time frame: 1 night

06

Study locations

1 site
  • Children's Hospital Srebrnjak
    Zagreb, 10000, Croatia
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03408990
Lead sponsor
Revenio Research
Collaborators
Children's Hospital Srebrnjak
Responsible party
Sponsor
First posted
Jan 24, 2018
Start date
Jan 26, 2018
Primary completion
Dec 27, 2018
Completion
Dec 27, 2018
Last update
May 21, 2019

Study contacts

Davor Plavec, MD, PhD
principal investigator · Children's Hospital Srebrnjak

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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