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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03785847
Enrollment
40
Registered
2018-12-24
Start date
2018-12-20
Completion date
2019-09-17
Last updated
2019-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiration Disorders

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

Interventions

DIAGNOSTIC_TESTVentica

Impedance pneumography measurement

Sponsors

Revenio Research
CollaboratorINDUSTRY
Tampere University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
12 Months to 71 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ventica measurementovernight measurementlevel of overnight tidal breathing flow volume variation

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026