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

October 24, 2019 updated by: Jussi Karjalainen, Tampere University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • TAYS Allergiakeskus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Sample of 40 healthy children aged 12 - 71 months.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ventica measurement
Time Frame: overnight measurement
level of overnight tidal breathing flow volume variation
overnight measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Collaborators

Revenio Research

Investigators

  • Principal Investigator: Jussi Karjalainen, MD, Tampere University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2018

Primary Completion (Actual)

September 17, 2019

Study Completion (Actual)

September 17, 2019

Study Registration Dates

First Submitted

December 20, 2018

First Submitted That Met QC Criteria

December 20, 2018

First Posted (Actual)

December 24, 2018

Study Record Updates

Last Update Posted (Actual)

October 28, 2019

Last Update Submitted That Met QC Criteria

October 24, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCS-008

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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