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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03551236
• Other study ID #: VCS-001
• Status: Completed
• Start date: January 17, 2017
• Est. completion date: July 3, 2017

Study information

• Verified date: May 2018
• Source: Revenio Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 3, 2017
• Est. primary completion date: July 3, 2017
• Gender: All
• Age group: N/A and older

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

Related Conditions & MeSH terms

• Healthy Subjects

Locations

Country	Name	City	State
Croatia	Children's Hospital Srebrnjak	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Revenio Research	Children's Hospital Srebrnjak

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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