Normal Variability of Tidal Breathing Flow-volume Curves... | NCT03785847

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

NCT03785847

Sponsor

Tampere University Hospital

Status

Completed

Last Update Posted

Oct 28, 2019Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Respiration Disorders

Interventions

Ventica

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 20, 2018Actual

Primary Completion Date

Sep 17, 2019Actual

Completion Date

Sep 17, 2019Actual

First Submitted Date

Dec 20, 2018

First Submission Date that Met QC Criteria

Dec 20, 2018

First Posted Date

Dec 24, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 24, 2019

Last Update Posted Date

Oct 28, 2019Actual

Name	Class
Revenio Research	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Name	Type	Description	Arm Group Labels	Other Names
Ventica	Diagnostic Test	Impedance pneumography measurement

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Months

Maximum Age

71 Months

Standard Ages

Child

Study Population

Sample of 40 healthy children aged 12 - 71 months.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jussi Karjalainen, MD	Tampere University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
TAYS Allergiakeskus		Tampere		33521	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21321385	Background	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.
23348215	Background	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.