NCT02557880

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

5 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2015

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

4 months

First QC Date

September 21, 2015

Last Update Submit

March 24, 2017

Conditions

Dyssomnias

Outcome Measures

Primary Outcomes (1)

  • Time to Bed

    improvement in consistency of time to bed

    1 month, 3 months, & 6 months

Secondary Outcomes (1)

  • Reaction Time

    1 month, 3 months, & 6 months

Study Arms (2)

Sleep Application Diary

EXPERIMENTAL

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 DiaryBehavioral: Treatment As Usual

Treatment as Usual

ACTIVE COMPARATOR

Sleep hygiene counseling

Behavioral: Treatment As Usual

Interventions

Sleep Application DiaryBEHAVIORAL

Tool used to document sleep hygiene.

Sleep Application Diary
Treatment As UsualBEHAVIORAL

Sleep hygiene counseling

Sleep Application DiaryTreatment as Usual

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • significant developmental delays
  • English is not the primary language spoken

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

30 Hope Drive

Hershey, Pennsylvania, 17033, United States

Location

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Penn State Hershey Children's Hospital-Lancaster Outpatient

Lancaster, Pennsylvania, 17603, United States

Location

Penn State Hershey Medical Group-St. Joes

Reading, Pennsylvania, 19605, United States

Location

Penn State Hershey Medical Group-York-Apple hill

York, Pennsylvania, 17403, United States

Location

Related Publications (7)

  • 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.

    PMID: 23771214BACKGROUND

  • 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.

    PMID: 24888483BACKGROUND

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

    BACKGROUND

  • 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/

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Dyssomnias

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Cheryl Tierney, MD, MPH

    Penn State College of Medicine, Milton S. Hershey Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 23, 2015

Study Start

September 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

US(5)