Confounding Factors of Impedance Pneumography

Confounding Factors of Impedance Pneumography Signal Changes During Sleep

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Sleep Apnea

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Children's Hospital Srebrnjak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects referred to sleep laboratory at the investigational site or healthy volunteers from Zagreb and surroundings

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sleep study for clinical reasons; Children referred to sleep study for clinical reasons
Healthy; 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

Collaborators and Investigators

• Sponsor: Revenio Research
• Collaborators: Children's Hospital Srebrnjak
• Investigators: Principal Investigator: Davor Plavec, MD, PhD, Children's Hospital Srebrnjak

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2018
• Primary Completion (Actual): December 27, 2018
• Study Completion (Actual): December 27, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 23, 2018
• First Posted (Actual): January 24, 2018

Study Record Updates

• Last Update Posted (Actual): May 21, 2019
• Last Update Submitted That Met QC Criteria: May 20, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: VCS-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No