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

NCT ID: NCT03785847

Last Updated: 2019-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-20

Study Completion Date

2019-09-17

Brief Summary

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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

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

Conditions

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Respiration Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Ventica

Impedance pneumography measurement

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

71 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Revenio Research

INDUSTRY

Sponsor Role collaborator

Tampere University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jussi Karjalainen

Head of Department, MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jussi Karjalainen, MD

Role: PRINCIPAL_INVESTIGATOR

Tampere University Hospital

Locations

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TAYS Allergiakeskus

Tampere, , Finland

Site Status

Countries

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Finland

References

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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.

Reference Type BACKGROUND
PMID: 21321385 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23348215 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24092693 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28182566 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26989106 (View on PubMed)

Other Identifiers

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VCS-008

Identifier Type: -

Identifier Source: org_study_id

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