Confounding Factors of Impedance Pneumography

NCT03408990 | Completed

• 1 other identifier: VCS-005
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Association between body/head positions and tidal breathing flow-volume (TBFV) curves

  1 night

Study Arms (2)

Sleep study for clinical reasons

Children referred to sleep study for clinical reasons

Healthy

Healthy children, no relevant pathologies

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 1-7 years, both sexes
• Referred to polysomnography
• Signed informed consent
• years, both sexes
• Lung function in the reference range
• Signed informed consent

You may not qualify if:

• 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)
• Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness (recurrent pneumonia)
• Hospital-treated for bronchiolitis with residual symptoms
• 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

Sponsors & Collaborators

• Revenio Research: lead
• Children's Hospital Srebrnjak: collaborator

Study Sites (1)

Children's Hospital Srebrnjak

Zagreb, 10000, Croatia

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Davor Plavec, MD, PhD

  Children's Hospital Srebrnjak

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2018
• First Posted: January 24, 2018
• Study Start: January 26, 2018
• Primary Completion: December 27, 2018
• Study Completion: December 27, 2018
• Last Updated: May 21, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)