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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02557880
Other study ID # STUDY00002530
Secondary ID
Status Withdrawn
Phase N/A
First received September 21, 2015
Last updated March 24, 2017
Start date September 2016
Est. completion date January 1, 2017

Study information

Verified date March 2017
Source Milton S. Hershey Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study will be to see if adolescents can advance bedtime above what can be accomplished by counseling alone simply by inputting their information into a sleep application diary and reporting this information back to their sleep doctor.


Description:

Using a smart phone application, participants will record bedtime and wake up times as well as answer questions about their sleep throughout their participation in this study . Reaction time will also be measured through a smart phone application.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date January 1, 2017
Est. primary completion date January 1, 2017
Accepts healthy volunteers No
Gender All
Age group 12 Years to 17 Years
Eligibility Inclusion Criteria:

- Males & Females age 12-17

- have access to a smart phone (iphone or android)

- present to a sleep disorder clinic with poor sleep hygiene and seen by a pediatric sleep specialist

Exclusion Criteria:

- significant developmental delays

- English is not the primary language spoken

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Sleep Application Diary
Tool used to document sleep hygiene.
Treatment As Usual
Sleep hygiene counseling

Locations

Country Name City State
United States 30 Hope Drive Hershey Pennsylvania
United States Penn State Hershey Medical Center Hershey Pennsylvania
United States Penn State Hershey Children's Hospital—Lancaster Outpatient Lancaster Pennsylvania
United States Penn State Hershey Medical Group—St. Joes Reading Pennsylvania
United States Penn State Hershey Medical Group—York—Apple hill York Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

Bassan, Fabio. (2014). Ultra Reaction—who is faster? (Version 1.5) [Mobile application software]. Retrieved from http://itunes.apple.com

Behar J, Roebuck A, Domingos JS, Gederi E, Clifford GD. A review of current sleep screening applications for smartphones. Physiol Meas. 2013 Jul;34(7):R29-46. doi: 10.1088/0967-3334/34/7/R29. Review. — View Citation

Egton Medical Information System Limited (2014). Sleep Diary Patient.co.uk (Version 1.3) [Mobile application software]. Retrieved from http://itunes.apple.com

Lenhart, A., Ling, R., Campbell, S., Purcell, K. (2010, April 20). Teens and Mobile Phones. Pew Research Center's Internet & Amerian Life Project. Retrieved December 8, 2011 from http://www.pewinternet.org/2010/04/20/teens-and-mobile-phones/

Qiwii. (2013). Reaction time (version 1.0.0). [Mobile application software]. Retrieved from http://play.google.com

Shirazi, Alireza Sahami, James Clawson, Yashar Hassanpour, Mohammad J. Tourian, Albrecht Schmidt, Ed H. Chi, Marko Borazio, and Kristof Van Laerhoven.

Stippig A, Hübers U, Emerich M. Apps in sleep medicine. Sleep Breath. 2015 Mar;19(1):411-7. doi: 10.1007/s11325-014-1009-6. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Time to Bed improvement in consistency of time to bed 1 month, 3 months, & 6 months
Secondary Reaction Time reaction time measured by reaction time test application 1 month, 3 months, & 6 months
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