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OpenTrials
Completed

NCT Number: NCT03785847

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

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.

Completed

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Key information

Age range

12 month–71 month

Sex eligibility

All sexes

Study type

Observational

Primary location

TAYS Allergiakeskus

Tampere, 33521, Finland

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ventica

Diagnostic Test

Impedance pneumography measurement

Primary outcomes

  1. Ventica measurement

    Time frame: overnight measurement

    level of overnight tidal breathing flow volume variation

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Revenio Research

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Dec 24, 2018
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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