Variability of Impedance Pneumography Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

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 Overview

• Status: Completed
• Conditions: Healthy Subjects

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Children's Hospital Srebrnjak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Young children screened to have small probability of asthma or wheezing

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1-3 nights per subject

Collaborators and Investigators

• Sponsor: Revenio Research
• Collaborators: Children's Hospital Srebrnjak
• Investigators: Principal Investigator: Davor Plavec, MD, PhD, Children's Hospital Srebrnjak

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2017
• Primary Completion (Actual): July 3, 2017
• Study Completion (Actual): July 3, 2017

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): June 11, 2018

Study Record Updates

• Last Update Posted (Actual): June 11, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: VCS-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No