Clinical trial NCT03785847: Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
Official title: Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiration Disorders
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
Collaborators: name: Revenio Research
First posted: 2018-12-24
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 71
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Sample of 40 healthy children aged 12 - 71 months.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Ventica measurement
timeFrame: overnight measurement
Secondary outcomes:
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: TAYS Allergiakeskus
Study officials:
affiliation: Tampere University Hospital
name: Jussi Karjalainen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.