DyssomniasNCT02557880
Sleep Application Diary and Sleep Hygiene in Adolescents
A study testing Sleep Application Diary and Treatment As Usual in people with Dyssomnias, run by Milton S. Hershey Medical Center at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Dyssomnias
- What is being tested?
- Sleep Application Diary and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2016to 1 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- significant developmental delays
- English is not the primary language spoken
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
30 Hope Drive
Hershey, Pennsylvania, 17033
Penn State Hershey Medical Center
Hershey, Pennsylvania, 17033
Penn State Hershey Children's Hospital-Lancaster Outpatient
Lancaster, Pennsylvania, 17603
Penn State Hershey Medical Group-St. Joes
Reading, Pennsylvania, 19605
Penn State Hershey Medical Group-York-Apple hill
York, Pennsylvania, 17403
About this study
Official title: 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.
Read the 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.
- Conditions
- Dyssomnias
- Being tested
- Sleep Application Diary, Treatment As Usual
- Medical subject headings
- Dyssomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Application DiaryBehavioural
Tool used to document sleep hygiene.
Treatment As UsualBehavioural
Sleep hygiene counseling
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Sleep Application Diary; Behavioral: Treatment As Usual |
| Treatment as Usual | Active comparator | Sleep hygiene counseling Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Bed
improvement in consistency of time to bed
Measured: 1 month, 3 months, & 6 months
Secondary outcomes (1)
Reaction Time
reaction time measured by reaction time test application
Measured: 1 month, 3 months, & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startSep 2016
- Primary completion1 Jan 2017
- Study completion1 Jan 2017
Why it stopped: Could not get teenagers to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for DyssomniasStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cheryl Tierney, Milton S. Hershey Medical Center
- Investigators
- Cheryl Tierney, MD, MPH, Principal investigator, Penn State College of Medicine, Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557880
- Sponsor's protocol ID
- STUDY00002530
- Status last verified
- Mar 2017
- First submitted
- 21 Sep 2015
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23771214Stippig 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.
PubMed 24888483Egton 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
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Utilization of a Sleep Application Diary Improve Sleep Hygiene in Adolescents?
- ClinicalTrials.gov ID
- NCT02557880
- Acronym / sponsor ID
- STUDY00002530
- Conditions
- Dyssomnias
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Could not get teenagers to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 1 Jan 2017 (actual)
- First posted
- 23 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Application Diary | Experimental | Behavioral: Sleep Application Diary, Behavioral: Treatment As UsualA sleep application diary which will automatically report results back to sleep doctor is used in addition to standard sleep hygiene counseling. |
| Treatment as Usual | Active comparator | Behavioral: Treatment As UsualSleep hygiene counseling |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- significant developmental delays
- English is not the primary language spoken
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Application DiaryTool used to document sleep hygiene. | Behavioural | Sleep Application Diary |
| Treatment As UsualSleep hygiene counseling | Behavioural | Sleep Application Diary, Treatment as Usual |
Primary outcome
Time to Bed
Time frame: 1 month, 3 months, & 6 months
improvement in consistency of time to bed
1 secondary outcome
Reaction Time
Time frame: 1 month, 3 months, & 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- Background: PubMed 23771214Behar 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.
- Background: PubMed 24888483Stippig 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.
- BackgroundEgton Medical Information System Limited (2014). Sleep Diary Patient.co.uk (Version 1.3) [Mobile application software]. Retrieved from http://itunes.apple.com
- BackgroundLenhart, 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/
- BackgroundShirazi, Alireza Sahami, James Clawson, Yashar Hassanpour, Mohammad J. Tourian, Albrecht Schmidt, Ed H. Chi, Marko Borazio, and Kristof Van Laerhoven.
- BackgroundBassan, Fabio. (2014). Ultra Reaction-who is faster? (Version 1.5) [Mobile application software]. Retrieved from http://itunes.apple.com
- BackgroundQiwii. (2013). Reaction time (version 1.0.0). [Mobile application software]. Retrieved from http://play.google.com
Related trials for Dyssomnias
Recruiting
Neurobehavioral Changes Following Spaceflight Stressors
Stressor, Individual, Alcohol Impairment
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
RecruitingPhase 2/3
A Study of TAK-360 in People With Narcolepsy or Idiopathic Hypersomnia
Idiopathic Hypersomnia, Narcolepsy Type 1
Not yet recruitingPhase 4
Lemborexant on Perioperative Sleep Quality in Patients Undergoing Breast Cancer Surgery
Postoperative Sleep Disturbance, Breast Cancer Surgery
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheryl Tierney, MD, MPH principal investigator
Penn State College of Medicine, Milton S. Hershey Medical Center
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Application Diary and Treatment As Usual in people with Dyssomnias, run by Milton S. Hershey Medical Center at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Bed (time frame: 1 month, 3 months, & 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02557880, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2017.