Sleep Application Diary and Sleep Hygiene in Adolescents

March 24, 2017 updated by: Cheryl Tierney, Milton S. Hershey Medical Center

Does the Utilization of a Sleep Application Diary Improve Sleep Hygiene in Adolescents?

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Medical Center
      • Hershey, Pennsylvania, United States, 17033
        • 30 Hope Drive
      • Lancaster, Pennsylvania, United States, 17603
        • Penn State Hershey Children's Hospital-Lancaster Outpatient
      • Reading, Pennsylvania, United States, 19605
        • Penn State Hershey Medical Group-St. Joes
      • York, Pennsylvania, United States, 17403
        • Penn State Hershey Medical Group-York-Apple hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Bed
Time Frame: 1 month, 3 months, & 6 months
improvement in consistency of time to bed
1 month, 3 months, & 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaction Time
Time Frame: 1 month, 3 months, & 6 months
reaction time measured by reaction time test application
1 month, 3 months, & 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Principal Investigator: Cheryl Tierney, MD, MPH, Penn State College of Medicine, Milton S. Hershey Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 21, 2015

First Submitted That Met QC Criteria

September 21, 2015

First Posted (Estimate)

September 23, 2015

Study Record Updates

Last Update Posted (Actual)

March 28, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00002530

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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