Confounding Factors of Impedance Pneumography

Healthy Clinical Trial

Official title:

Confounding Factors of Impedance Pneumography Signal Changes During Sleep

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03408990
• Other study ID #: VCS-005
• Status: Completed
• Start date: January 26, 2018
• Est. completion date: December 27, 2018

Study information

• Verified date: May 2019
• Source: Revenio Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 27, 2018
• Est. primary completion date: December 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Sleep Apnea

Locations

Country	Name	City	State
Croatia	Children's Hospital Srebrnjak	Zagreb

Sponsors (2)

Lead Sponsor	Collaborator
Revenio Research	Children's Hospital Srebrnjak

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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