Confounding Factors of Impedance Pneumography

NCT ID: NCT03408990

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-01-26
• Study Completion Date: 2018-12-27

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Sleep study for clinical reasons

Children referred to sleep study for clinical reasons

No interventions assigned to this group

Healthy

Healthy children, no relevant pathologies

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Age 1-7 years, both sexes
• Referred to polysomnography
• Signed informed consent

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital Srebrnjak

OTHER

Sponsor Role: collaborator

Revenio Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Davor Plavec, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Srebrnjak

Locations

Children's Hospital Srebrnjak

Zagreb, , Croatia

Countries

Croatia

Other Identifiers

VCS-005

Identifier Type: -

Identifier Source: org_study_id