Confounding Factors of Impedance Pneumography

Completed

• Conditions: Healthy; Sleep Apnea

• Registration Number: NCT03408990
• Lead Sponsor: Revenio Research

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-01-16
• Study First Submitted QC: 2018-01-23
• Study First Posted: 2018-01-24
• Study Start: 2018-01-26
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-20
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Children's Hospital Srebrnjak; 🇭🇷 Zagreb, Croatia