Skip to main content
OpenTrials
Completed

NCT Number: NCT03408990

Confounding Factors of Impedance Pneumography

The purpose of this study is to evaluate the association of signals recorded and analysed with Ventica® Lung Function Testing System (LFTS) in infants and pre-schoolers during the whole night sleep with the gold standard for sleep recording events, polysomnography, in order to better understand the confounding factors for momentary changes in the impedance pneumography-derived tidal breathing flow-volume (TBFV) curves.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Who can participate

Healthy volunteers accepted: Yes

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

Group 1: (children referred to sleep study for clinical reasons) Inclusion criteria:

  • Age 1-7 years, both sexes
  • Referred to polysomnography
  • Signed informed consent

Group 2: (healthy children) Inclusion criteria:

  • 2-7 years, both sexes
  • Healthy at the time of inclusion based on history and clinical examination according to the investigator judgement
  • Lung function in the reference range
  • Signed informed consent

Exclusion criteria

  • Preterm birth with chronic respiratory disorder of prematurity
  • Significant nasal congestion or adenotonsillar hypertrophy with signs and symptoms of sleep apnea or sleep disordered breathing
  • Chronic rhinosinusitis, synonasal polyposis
  • 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
  • Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
  • Hospital-treated for bronchiolitis with residual symptoms
  • Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion
  • Other cardiorespiratory or neurological chronic diseases or states that may significantly alter the overnight breathing pattern
  • Implanted or external active medical devices
  • Long lasting respiratory events during the polysomnography study like continuous upper airway limitation

Treatment and study plan

Primary outcomes

  1. Association between sleep stages and tidal breathing flow-volume (TBFV) curves

    Time frame: 1 night

    Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep

Secondary outcomes

  1. Association between body/head positions and tidal breathing flow-volume (TBFV) curves

    Time frame: 1 night

    Assess the correlation between Ventica-derived TBFV curves within and between different body/head positions (derived from video and/or positional sensors) during night sleep

Sponsors and collaborators

Lead sponsor

Revenio Research

Industry

Collaborators

  • Children's Hospital Srebrnjak

Registry information

Official study title

Confounding Factors of Impedance Pneumography Signal Changes During Sleep

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 24, 2018
Registry last updated
May 21, 2019

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.

Published trials that share one or more normalized conditions with this study.