Sleep Hygiene, InadequateNCT03177421
Health Information Technology to Improve Bedtime Media Use in Children
A study testing Problematic bedtime media use counseling and Sleep problem counseling in people with Sleep Hygiene, Inadequate, run by Indiana University at 2 sites in United States.
Trial summary
The objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Sleep Hygiene, Inadequate
- What is being tested?
- Problematic bedtime media use counseling and Sleep problem counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60,100 participants
- Where
- 2 sitesUnited States
- Study dates
- 13 Jun 2017to 31 May 2019
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Attend a participating clinic
- Complete a prescreener form in the clinic
Who cannot join
- None
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
Riley Hospital for Children
Indianapolis, Indiana, 46202
About this study
Official title: Improving Bedtime Media Use and Sleep Through Health Information Technology
The objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use. Participants will be randomized by clinic to be screened for basic sleep concerns and receive appropriate counseling, or to be screened for sleep concerns and media use, and receive appropriate counseling.
Read the detailed description
Children and adolescents are increasingly integrating media and technology into daily life. A large body of research has shown poor sleep-related outcomes related to media exposure, especially in evening or bedtime hours - a trend that holds true from infancy to adolescence. Prior research has demonstrated clinic-based interventions can be effective in reducing general screen time. Yet, little work has been done to leverage existing health information technology to adapt bedtime media use guidelines into sustainable counseling interventions. This study will develop, implement, and evaluate a computerized, evidence-based decision support intervention for reducing inappropriate childhood bedtime media use and improving sleep measures.
- Conditions
- Sleep Hygiene, Inadequate
- Being tested
- Problematic bedtime media use counseling, Sleep problem counseling
- Medical subject headings
- Sleep Hygiene
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problematic bedtime media use counselingOther
Also called Intervention
Participants will be screened for bedtime media use and sleep problems, and the clinical decision support system will recommend counseling on the respective problems identified on screening.
Sleep problem counselingOther
Also called Control
Participants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified.
| Study group | Role | What they receive |
|---|---|---|
| Bedtime media use and sleep problems | Experimental | This arm will receive screening for and associated clinical decision support on sleep problems and bedtime media use. Receives: Other: Problematic bedtime media use counseling |
| Sleep problems only | Other | This arm will receive screening for and associated clinical decision support on sleep problems only. Receives: Other: Sleep problem counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of clinician counseling for problematic bedtime media use and sleep problems
Measured: Up to 3 years
Secondary outcomes (3)
Change in bedtime media use following clinician counseling
Measured: Up to 3 years
Change in inadequate sleep quantity following clinician counseling
Measured: Up to 3 years
Change in daytime sleepiness following clinician counseling
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start13 Jun 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: Study technology decommissioned at clinical site.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Hygiene, InadequateStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Midway through the study, participants from the control group will be folded into the intervention group.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60,100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randall Grout, Indiana University
- Investigators
- Randall W. Grout, MD, MS, Principal investigator, Indiana University - Ped Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177421
- Sponsor's protocol ID
- chsr_bedtime-media-cdss_2017
- Status last verified
- Jan 2022
- First submitted
- 2 Jun 2017
- Last updated
- 9 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Bedtime Media Use and Sleep Through Health Information Technology
- ClinicalTrials.gov ID
- NCT03177421
- Acronym / sponsor ID
- chsr_bedtime-media-cdss_2017
- Conditions
- Sleep Hygiene, Inadequate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study technology decommissioned at clinical site.
- Enrolment
- 60,100 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 13 Jun 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 6 Jun 2017 (actual)
- 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 objective of this study is to use health information technology to implement and evaluate a counseling recommendation for children who suffer from problematic sleep associated with bedtime media use. Participants will be randomized by clinic to be screened for basic sleep concerns and receive appropriate counseling, or to be screened for sleep concerns and media use, and receive appropriate counseling.
Detailed description
Children and adolescents are increasingly integrating media and technology into daily life. A large body of research has shown poor sleep-related outcomes related to media exposure, especially in evening or bedtime hours - a trend that holds true from infancy to adolescence. Prior research has demonstrated clinic-based interventions can be effective in reducing general screen time. Yet, little work has been done to leverage existing health information technology to adapt bedtime media use guidelines into sustainable counseling interventions. This study will develop, implement, and evaluate a computerized, evidence-based decision support intervention for reducing inappropriate childhood bedtime media use and improving sleep measures.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Midway through the study, participants from the control group will be folded into the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Bedtime media use and sleep problems | Experimental | Other: Problematic bedtime media use counselingThis arm will receive screening for and associated clinical decision support on sleep problems and bedtime media use. |
| Sleep problems only | Other | Other: Sleep problem counselingThis arm will receive screening for and associated clinical decision support on sleep problems only. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Attend a participating clinic
- Complete a prescreener form in the clinic
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Problematic bedtime media use counselingAlso: InterventionParticipants will be screened for bedtime media use and sleep problems, and the clinical decision support system will recommend counseling on the respective problems identified on screening. | Other | Bedtime media use and sleep problems |
| Sleep problem counselingAlso: ControlParticipants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified. | Other | Sleep problems only |
Primary outcome
Rate of clinician counseling for problematic bedtime media use and sleep problems
Time frame: Up to 3 years
3 secondary outcomes
Change in bedtime media use following clinician counseling
Time frame: Up to 3 years
Change in inadequate sleep quantity following clinician counseling
Time frame: Up to 3 years
Change in daytime sleepiness following clinician counseling
Time frame: Up to 3 years
Results and safety
The study was stopped early (reason given: Study technology decommissioned at clinical site.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2022.
- Individual participant dataSharing planned: No
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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.
Randall W. Grout, MD, MS principal investigator
Indiana University - Ped Health Services
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problematic bedtime media use counseling and Sleep problem counseling in people with Sleep Hygiene, Inadequate, run by Indiana University at 2 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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 9 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 stopped early (reason given: Study technology decommissioned at clinical site.). Results are not available in the source record.
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?
Rate of clinician counseling for problematic bedtime media use and sleep problems (time frame: Up to 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Feb 2022.