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

Completed

• Conditions: Healthy Subjects

• Registration Number: NCT03551236
• Lead Sponsor: Revenio Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01-17
• Primary Completion: 2017-07-03
• Study Completion: 2017-07-03
• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-05-28
• Last Update Submitted: 2018-05-28
• Study First Posted: 2018-06-11
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Not specified
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital Srebrnjak; 🇭🇷 Zagreb, Croatia