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Sleep Application Diary and Sleep Hygiene in Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02557880
Recruitment Status : Withdrawn (Could not get teenagers to enroll)
First Posted : September 23, 2015
Last Update Posted : March 28, 2017
Sponsor:
Information provided by (Responsible Party):
Cheryl Tierney, Milton S. Hershey Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Dyssomnias Behavioral: Sleep Application Diary Behavioral: Treatment As Usual Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does the Utilization of a Sleep Application Diary Improve Sleep Hygiene in Adolescents?
Study Start Date : September 2016
Actual Primary Completion Date : January 1, 2017
Actual Study Completion Date : January 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Healthy Sleep

Arm Intervention/treatment
Experimental: Sleep Application Diary
A sleep application diary which will automatically report results back to sleep doctor is used in addition to standard sleep hygiene counseling.
Behavioral: Sleep Application Diary
Tool used to document sleep hygiene.

Behavioral: Treatment As Usual
Sleep hygiene counseling

Active Comparator: Treatment as Usual
Sleep hygiene counseling
Behavioral: Treatment As Usual
Sleep hygiene counseling




Primary Outcome Measures :
  1. Time to Bed [ Time Frame: 1 month, 3 months, & 6 months ]
    improvement in consistency of time to bed


Secondary Outcome Measures :
  1. Reaction Time [ Time Frame: 1 month, 3 months, & 6 months ]
    reaction time measured by reaction time test application



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02557880


Locations
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United States, Pennsylvania
30 Hope Drive
Hershey, Pennsylvania, United States, 17033
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Penn State Hershey Children's Hospital—Lancaster Outpatient
Lancaster, Pennsylvania, United States, 17603
Penn State Hershey Medical Group—St. Joes
Reading, Pennsylvania, United States, 19605
Penn State Hershey Medical Group—York—Apple hill
York, Pennsylvania, United States, 17403
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Cheryl Tierney, MD, MPH Penn State College of Medicine, Milton S. Hershey Medical Center
Publications:
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/
Shirazi, Alireza Sahami, James Clawson, Yashar Hassanpour, Mohammad J. Tourian, Albrecht Schmidt, Ed H. Chi, Marko Borazio, and Kristof Van Laerhoven.
Bassan, Fabio. (2014). Ultra Reaction—who is faster? (Version 1.5) [Mobile application software]. Retrieved from http://itunes.apple.com
Qiwii. (2013). Reaction time (version 1.0.0). [Mobile application software]. Retrieved from http://play.google.com

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Responsible Party: Cheryl Tierney, Associate Professor, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT02557880    
Other Study ID Numbers: STUDY00002530
First Posted: September 23, 2015    Key Record Dates
Last Update Posted: March 28, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Mental Disorders