Lung Function Variability in Children and Adolescents

Summary

Long-term variability analysis of peak expiratory flow (PEF) and forced expiratory volume in 1 s (FEV1) has been successfully used in research to predict the exacerbation of the disease in adult individuals with asthma. However, there is a paucity of data regarding PEF and FEV1 variability in asthmatic children and adolescents. Such a task requires at least daily PEF and FEV1 measurements, recording in diaries, and periodic evaluation of the data. The process may be proven both complicated and time consuming, thus reducing patients' adherence. Recent advances in biosensor technology have permitted the development of reliable, low-cost, portable spirometers, able to connect with smartphones and monitor lung function parameters in real time and from a distance.

The objectives of the present study is the assessment of PEF and FEV1 variability: a) in healthy children and adolescents, in order to define the normal daily fluctuation of PEF and FEV1 and the parameters that may influence it, and b) in children and adolescents with asthma, in order to explore the differences from healthy subjects and reveal any specific variability changes prior to exacerbation. Such data would improve our understanding regarding the disease and permit the development of integrated tools for assessing the level of asthma control and the risk of future exacerbations.

The study will include 100 healthy children and adolescents aged 6 to 18 years for the assessment of normal PEF and FEV1 variability, and 100 children and adolescents of the same age with diagnosed asthma for the assessment of PEF and FEV1 variability in asthmatics. PEF and FEV1 measurements will be performed using an FDA-approved portable spirometer (MIR Spirobank Smart) capable to connect to smartphone. Each participant will receive his personal spirometer. Measurements will be performed twice a day between 07:00-09:00 and 19:00-21:00 hours and dispatched via email to a central database for a period of 3 months. PEF and FEV1 variability will be assessed by detrended fluctuation analysis, aiming to define the normal pattern (healthy controls) and to detect and quantify the deviations (asthmatics). The anticipated duration of the study is 24 months.

Conditions

• Asthma in Children
• Lung Function Decreased

Interventions

DIAGNOSTIC_TEST

Measurements of PEF and FEV1

Measurements of PEF and FEV1 at home, twice a day (07:00 - 09:00 and 19:00 - 21:00) and for a period of 3 months, using portable spirometers connected to smartphone

Sponsors & Collaborators

• University of Patras

  lead OTHER

Principal Investigators

• Sotirios Fouzas · University of Patras

Study Design

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

6 Years

Max Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-01-01

Primary Completion

2022-01-01

Completion

2023-01-01

Countries

• Greece

Study Locations