An observational study in Healthy and Sleep Apnea, sponsored by Revenio Research. Completed at 1 site in Croatia. Open to participants aged 1 Year to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by Revenio Research · Observational
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.
Subjects referred to sleep laboratory at the investigational site or healthy volunteers from Zagreb and surroundings
Group 1: (children referred to sleep study for clinical reasons) Inclusion criteria:
Group 2: (healthy children) Inclusion criteria:
Exclusion Criteria:
Children referred to sleep study for clinical reasons
Healthy children, no relevant pathologies
Association between sleep stages and tidal breathing flow-volume (TBFV) curves
Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep
Time frame: 1 night
Association between body/head positions and tidal breathing flow-volume (TBFV) curves
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
Time frame: 1 night
Plan to share: No
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