Confounding Factors of Impedance Pneumography

Study Overview
=================
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.

Official Title
-----------------
Confounding Factors of Impedance Pneumography Signal Changes During Sleep

Conditions
-----------------
Healthy, Sleep Apnea

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sleep study for clinical reasons<br>Children referred to sleep study for clinical reasons | |
| Healthy<br>Healthy children, no relevant pathologies | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 night | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 night |