Status:

COMPLETED

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

Lead Sponsor:

Tampere University Hospital

Collaborating Sponsors:

Revenio Research

Conditions:

Respiration Disorders

Eligibility:

All Genders

12-71 years

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

  • Age 12 months-71 months, both sexes
  • Healthy at the time of inclusion
  • Signed informed consent

Exclusion

  • 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

Key Trial Info

Start Date :

December 20 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 17 2019

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT03785847

Start Date

December 20 2018

End Date

September 17 2019

Last Update

October 28 2019

Active Locations (1)

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TAYS Allergiakeskus

Tampere, Finland, 33521