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

NCT03785847 | Completed

• 1 other identifier: VCS-008
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Respiration Disorders

Outcome Measures

Primary Outcomes (1)

• Ventica measurement

  level of overnight tidal breathing flow volume variation

  overnight measurement

Interventions

Ventica DIAGNOSTIC_TEST

Impedance pneumography measurement

Eligibility Criteria

• Age: 12 Months - 71 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Sample of 40 healthy children aged 12 - 71 months.

You may qualify if:

• Age 12 months-71 months, both sexes
• Signed informed consent

You may not qualify if:

• 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
• 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
• Any major chronic illness as judged by the investigators
• Implanted or external active medical devices such as pacemakers

Sponsors & Collaborators

• Tampere University Hospital: lead
• Revenio Research: collaborator

Study Sites (1)

TAYS Allergiakeskus

Tampere, 33521, Finland

Location

Related Publications (5)

• Seppa 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.

  PMID: 21321385 BACKGROUND

• Seppa 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.

  PMID: 23348215 BACKGROUND

• Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Makela 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.

  PMID: 24092693 BACKGROUND

• Malmberg LP, Seppa VP, Kotaniemi-Syrjanen A, Malmstrom K, Kajosaari M, Pelkonen AS, Viik J, Makela MJ. Measurement of tidal breathing flows in infants using impedance pneumography. Eur Respir J. 2017 Feb 15;49(2):1600926. doi: 10.1183/13993003.00926-2016. Print 2017 Feb.

  PMID: 28182566 BACKGROUND

• Seppa VP, Pelkonen AS, Kotaniemi-Syrjanen A, Viik J, Makela 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.

  PMID: 26989106 BACKGROUND

MeSH Terms

Conditions

Respiration Disorders

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Jussi Karjalainen, MD

  Tampere University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department, MD, PhD

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: December 20, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: October 28, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)