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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03551236

Enrollment

Registered

2018-06-11

Start date

2017-01-17

Completion date

2017-07-03

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Subjects

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

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

Design outcomes

Primary

Measure	Time frame	Description
Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)	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

Countries

Croatia

Outcome results