Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

Respiration Disorders Clinical Trial

Official title:

Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03785847
• Other study ID #: VCS-008
• Status: Completed
• Start date: December 20, 2018
• Est. completion date: September 17, 2019

Study information

• Verified date: October 2019
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study includes a comprehensive health examination with focus on respiratory health and the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy children.

Description:

Impedance pneumograpy results in healthy children to generate normal values and to stude the effect of age and gender

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 17, 2019
• Est. primary completion date: September 17, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Months to 71 Months

Eligibility

Inclusion Criteria:

• Age 12 months-71 months, both sexes

• Healthy at the time of inclusion

• Signed informed consent

Exclusion Criteria:

• Preterm birth

• Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness

• Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing

• Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion

• Personal or family history of asthma

• Recurrent wheezing without respiratory infection

• Allergic rhinitis, chronic rhinosinusitis, or other chronic respiratory disorders

• Atopic dermatitis

• Diagnosed allergic sensitization

• Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion

• Any major chronic illness as judged by the investigators

• Implanted or external active medical devices such as pacemakers

Related Conditions & MeSH terms

• Respiration Disorders

Intervention

Diagnostic Test:
• Ventica
Impedance pneumography measurement

Locations

Country	Name	City	State
Finland	TAYS Allergiakeskus	Tampere

Sponsors (2)

Lead Sponsor	Collaborator
Tampere University Hospital	Revenio Research

Country where clinical trial is conducted

Finland, 

References & Publications (5)

Malmberg LP, Seppä VP, Kotaniemi-Syrjänen A, Malmström K, Kajosaari M, Pelkonen AS, Viik J, Mäkelä MJ. Measurement of tidal breathing flows in infants using impedance pneumography. Eur Respir J. 2017 Feb 15;49(2). pii: 1600926. doi: 10.1183/13993003.00926-2016. Print 2017 Feb. — View Citation

Seppä VP, Hyttinen J, Uitto M, Chrapek W, Viik J. Novel electrode configuration for highly linear impedance pneumography. Biomed Tech (Berl). 2013 Feb;58(1):35-8. doi: 10.1515/bmt-2012-0068. — View Citation

Seppä VP, Hyttinen J, Viik J. A method for suppressing cardiogenic oscillations in impedance pneumography. Physiol Meas. 2011 Mar;32(3):337-45. doi: 10.1088/0967-3334/32/3/005. Epub 2011 Feb 14. — View Citation

Seppä VP, Pelkonen AS, Kotaniemi-Syrjänen A, Mäkelä MJ, Viik J, Malmberg LP. Tidal breathing flow measurement in awake young children by using impedance pneumography. J Appl Physiol (1985). 2013 Dec;115(11):1725-31. doi: 10.1152/japplphysiol.00657.2013. Epub 2013 Oct 3. — View Citation

Seppä VP, Pelkonen AS, Kotaniemi-Syrjänen A, Viik J, Mäkelä MJ, Malmberg LP. Tidal flow variability measured by impedance pneumography relates to childhood asthma risk. Eur Respir J. 2016 Jun;47(6):1687-96. doi: 10.1183/13993003.00989-2015. Epub 2016 Mar 17. Erratum in: Eur Respir J. 2016 Jul;48(1):285. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventica measurement	level of overnight tidal breathing flow volume variation	overnight measurement