search
Back to results

Sleep Application Diary and Sleep Hygiene in Adolescents

Primary Purpose

Dyssomnias

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Application Diary
Treatment As Usual
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyssomnias

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 30 Hope Drive
  • Penn State Hershey Medical Center
  • Penn State Hershey Children's Hospital-Lancaster Outpatient
  • Penn State Hershey Medical Group-St. Joes
  • Penn State Hershey Medical Group-York-Apple hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sleep Application Diary

Treatment as Usual

Arm Description

A sleep application diary which will automatically report results back to sleep doctor is used in addition to standard sleep hygiene counseling.

Sleep hygiene counseling

Outcomes

Primary Outcome Measures

Time to Bed
improvement in consistency of time to bed

Secondary Outcome Measures

Reaction Time
reaction time measured by reaction time test application

Full Information

First Posted
September 21, 2015
Last Updated
March 24, 2017
Sponsor
Milton S. Hershey Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT02557880
Brief Title
Sleep Application Diary and Sleep Hygiene in Adolescents
Official Title
Does the Utilization of a Sleep Application Diary Improve Sleep Hygiene in Adolescents?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
Could not get teenagers to enroll
Study Start Date
September 2016 (undefined)
Primary Completion Date
January 1, 2017 (Actual)
Study Completion Date
January 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyssomnias

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sleep Application Diary
Arm Type
Experimental
Arm Description
A sleep application diary which will automatically report results back to sleep doctor is used in addition to standard sleep hygiene counseling.
Arm Title
Treatment as Usual
Arm Type
Active Comparator
Arm Description
Sleep hygiene counseling
Intervention Type
Behavioral
Intervention Name(s)
Sleep Application Diary
Intervention Description
Tool used to document sleep hygiene.
Intervention Type
Behavioral
Intervention Name(s)
Treatment As Usual
Intervention Description
Sleep hygiene counseling
Primary Outcome Measure Information:
Title
Time to Bed
Description
improvement in consistency of time to bed
Time Frame
1 month, 3 months, & 6 months
Secondary Outcome Measure Information:
Title
Reaction Time
Description
reaction time measured by reaction time test application
Time Frame
1 month, 3 months, & 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheryl Tierney, MD, MPH
Organizational Affiliation
Penn State College of Medicine, Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
30 Hope Drive
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Penn State Hershey Children's Hospital-Lancaster Outpatient
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17603
Country
United States
Facility Name
Penn State Hershey Medical Group-St. Joes
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19605
Country
United States
Facility Name
Penn State Hershey Medical Group-York-Apple hill
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17403
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23771214
Citation
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. Epub 2013 Jun 17.
Results Reference
background
PubMed Identifier
24888483
Citation
Stippig A, Hubers U, Emerich M. Apps in sleep medicine. Sleep Breath. 2015 Mar;19(1):411-7. doi: 10.1007/s11325-014-1009-6. Epub 2014 Jun 3.
Results Reference
background
Citation
Egton Medical Information System Limited (2014). Sleep Diary Patient.co.uk (Version 1.3) [Mobile application software]. Retrieved from http://itunes.apple.com
Results Reference
background
Citation
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/
Results Reference
background
Citation
Shirazi, Alireza Sahami, James Clawson, Yashar Hassanpour, Mohammad J. Tourian, Albrecht Schmidt, Ed H. Chi, Marko Borazio, and Kristof Van Laerhoven.
Results Reference
background
Citation
Bassan, Fabio. (2014). Ultra Reaction-who is faster? (Version 1.5) [Mobile application software]. Retrieved from http://itunes.apple.com
Results Reference
background
Citation
Qiwii. (2013). Reaction time (version 1.0.0). [Mobile application software]. Retrieved from http://play.google.com
Results Reference
background

Learn more about this trial

Sleep Application Diary and Sleep Hygiene in Adolescents

We'll reach out to this number within 24 hrs