Automated Device for Asthma Monitoring - Full Text View

Purpose

This study will examine an innovative strategy to monitor asthma symptoms by using existing technology to develop a non-invasive device for monitoring asthma symptoms in adolescents. Using an iPod as a platform, and current sound data analysis techniques, a prototype device will be developed that will directly monitor the chosen parameters of asthma symptoms, including wheezing, coughing and activity levels. This small non-invasive device will be continuously carried by or placed in close proximity to the adolescent on a daily basis. It is hypothesized that such a device would be acceptable to adolescents and would lend accuracy and objectivity to symptom assessment; something that existing monitoring strategies have yet to achieve. It will also stimulate the adolescents' partnership in asthma self-monitoring and ultimately lead to effective asthma management.

Condition	Intervention
Asthma	Device: Automated Device for Asthma Monitoring (ADAM)

Study Type:	Observational
Study Design:	Observational Model: Case Control Time Perspective: Prospective
Official Title:	Developing an Automated Symptom Monitoring Device for Adolescents With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma Cough

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

number of coughs per 24 hours [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.

Secondary Outcome Measures:

Number of wheezes per 24 hours [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The device is supposed to detect and count the number of wheezes per 24 hours and register the numbers into the device.

Enrollment:	84
Study Start Date:	August 2009
Study Completion Date:	July 2012
Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Adolescents with asthma Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.	Device: Automated Device for Asthma Monitoring (ADAM) Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.
Adolescents without asthma Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.	Device: Automated Device for Asthma Monitoring (ADAM) Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.

Groups/Cohorts

Assigned Interventions

Adolescents with asthma

Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.

Device: Automated Device for Asthma Monitoring (ADAM)

Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.

Adolescents without asthma

Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.

Device: Automated Device for Asthma Monitoring (ADAM)

Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.

Show Detailed Description

Eligibility

Ages Eligible for Study:	13 Years to 17 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adolescents between the ages of 13-17 who received care at Strong Memorial Hospital, Rochester NY.

Criteria

Inclusion Criteria: Asthma Group

Age 13 through 17 years,
Asthma diagnosis from a care provider,
Prescribed asthma controller medication

Inclusion Criteria: Comparison(Non-asthma)Group

Age 13 through 17 years,

Exclusion Criteria: Asthma Group

Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
Ability to understand spoken and written English.

Exclusion Criteria: Comparison(Non-asthma)Group

Other health conditions (e.g., heart disease, cystic fibrosis) producing asthma-like symptoms,
Known cognitive, psychological and behavior problems (based on self-report and/or clinician report) that present challenges in following study procedures
Ability to understand spoken and written English.
Asthma diagnosis from a care provider,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696357

Locations

United States, New York
University of Rochester
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

Investigators

Principal Investigator:	Hyekyun Rhee, PhD, RN, PNP	University of Rochester School of Nursing
Principal Investigator:	Mark Bocko, PhD	University of Rochester Electrical Engineering

More Information

No publications provided

Responsible Party:	University of Rochester
ClinicalTrials.gov Identifier:	NCT01696357 History of Changes
Other Study ID Numbers:	5RO1NR11169-02
Study First Received:	September 18, 2012
Last Updated:	September 28, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Rochester:

Asthma
Adolescents
Self-monitoring
Quality of life

Biomedical device
Symptom monitoring
Self-management

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 17, 2013