Trial Outcomes & Findings for Automated Device for Asthma Monitoring (NCT NCT01696357)

Results Overview

The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.

Recruitment status

COMPLETED

Target enrollment

84 participants

Primary outcome timeframe

7 days

Results posted on

2014-12-10

Participant Flow

Participant milestones

Participant milestones
Measure	Adolescents With Asthma Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication. 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. 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.
Overall Study STARTED	42	42
Overall Study COMPLETED	40	41
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Automated Device for Asthma Monitoring

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Adolescents With Asthma n=42 Participants Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication. 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 n=42 Participants Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms. 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.	Total n=84 Participants Total of all reporting groups
Age, Continuous	15.2 years STANDARD_DEVIATION 1.5 • n=93 Participants	14.8 years STANDARD_DEVIATION 1.3 • n=4 Participants	15.0 years STANDARD_DEVIATION 1.4 • n=27 Participants
Sex: Female, Male Female	25 Participants n=93 Participants	26 Participants n=4 Participants	51 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Region of Enrollment United States	42 participants n=93 Participants	42 participants n=4 Participants	84 participants n=27 Participants

PRIMARY outcome

Timeframe: 7 days

Population: One subject in the non-asthma group failed to return the device after the 7-trial. Data from 22 participants (3 from the asthma group, 19 from non-asthma group) were not included in the analysis as no data were recorded (due to a mechanical issue) or data were too extreme (due to cough algorithm failure).

The device is supposed to detect and count the number of coughs per 24 hours and register the numbers into the device.

Outcome measures

Outcome measures
Measure	Adolescents With Asthma n=39 Participants Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication. 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 n=22 Participants Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms. 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.
Average Number of Coughs Per Hour	57.64 average number of coughs per hour Standard Deviation 111.41	.63 average number of coughs per hour Standard Deviation .76

Adverse Events

Adolescents With Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adolescents Without Asthma

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Hyekyun Rhee

University of Rochester Medical Center

Phone: 5852763775

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place