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OpenTrials
Completed

NCT Number: NCT03551236

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.

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Key information

Conditions

Healthy Subjects

Study type

Observational

Primary location

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Normal range of variables of tidal breathing flow-volume curves (CSRmin, NLmin, etc.)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Revenio Research

Industry

Collaborators

  • Children's Hospital Srebrnjak

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jun 11, 2018
Registry last updated
Jun 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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