NCT03551236

Brief 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 factors on the Ventica results.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2017

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2017

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 11, 2018

Completed
Last Updated

June 11, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

May 28, 2018

Last Update Submit

May 28, 2018

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Young children screened to have small probability of asthma or wheezing

You may qualify if:

  • months-6 years, both sexes
  • 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

You may not qualify if:

  • 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
  • Personal or family history or clinical evidence of asthma, atopy or other chronic respiratory disorders (high risk for asthma and allergy)
  • Implanted or external active medical devices such as pacemakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Location

Study Officials

  • Davor Plavec, MD, PhD

    Children's Hospital Srebrnjak

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 28, 2018

First Posted

June 11, 2018

Study Start

January 17, 2017

Primary Completion

July 3, 2017

Study Completion

July 3, 2017

Last Updated

June 11, 2018

Record last verified: 2018-05

Locations

CR(1)