Healthy, Sleep Apnea
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Children's Hospital Srebrnjak
Revenio Research
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
1 Years to 7 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Association between sleep stages and tidal breathing flow-volume (TBFV) curves | 1 night | Assess the correlation between Ventica-derived TBFV curves within and between different EEG-derived sleep stages during night sleep |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between body/head positions and tidal breathing flow-volume (TBFV) curves | 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 |
Countries
Croatia
Outcome results
None listed