InsomniaNCT01729715
Helping Young Children Sleep
A study testing Internet and DVD in people with Insomnia, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Insomnia
- What is being tested?
- Internet and DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Mar 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 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-36 months
- difficulties falling asleep or staying asleep
- DVD and internet access
Who cannot join
- Under 14 pounds
- Requires nighttime feeding or parental intervention for health reasons
- Chronic medical or psychological conditions such as asthma or autism
- Parents prefer co-sleeping
Trial locations and contacts
1 site in 1 country.
United States1 site
Nationwide Children's Hospital
Columbus, Ohio, 43205
About this study
The investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.
- Conditions
- Insomnia
- Being tested
- Internet, DVD
- Keywords
- Pediatric, Insomnia
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InternetBehavioural
DVDBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Internet | Experimental | Internet site that offers parents tips on promoting sleep in infants and toddlers Receives: Behavioral: Internet |
| DVD | Experimental | DVD that offers parents tips on promoting sleep in infants and toddlers Receives: Behavioral: DVD |
| No treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief infant sleep questionnaire
infant sleep patterns and sleep problems
Measured: 3 weeks
Secondary outcomes (2)
Profile of mood states
parental mood in the past week
Measured: 1 week
Pittsburgh sleep quality index
parental sleep patterns within the past month
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionNov 2015
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark Splaingard, Nationwide Children's Hospital
- Investigators
- Mark Splaingard, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01729715
- Sponsor's protocol ID
- IRB12-00439
- Status last verified
- Jul 2017
- First submitted
- 15 Nov 2012
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Helping Young Children Sleep
- ClinicalTrials.gov ID
- NCT01729715
- Acronym / sponsor ID
- IRB12-00439
- Conditions
- Insomnia
- Keywords
- Pediatric, Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Nov 2015 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 20 Nov 2012 (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 investigators are conducting a randomized trial of behavioral treatments for young children with insomnia. The investigators are comparing the improvement in sleep patterns after families are given access to Internet sleep instructions compared to DVD sleep instructions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet | Experimental | Behavioral: InternetInternet site that offers parents tips on promoting sleep in infants and toddlers |
| DVD | Experimental | Behavioral: DVDDVD that offers parents tips on promoting sleep in infants and toddlers |
| No treatment | No intervention | – |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 6-36 months
- difficulties falling asleep or staying asleep
- DVD and internet access
Key exclusion criteria (4 listed)
- Under 14 pounds
- Requires nighttime feeding or parental intervention for health reasons
- Chronic medical or psychological conditions such as asthma or autism
- Parents prefer co-sleeping
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 |
|---|---|---|
| Internet | Behavioural | Internet |
| DVD | Behavioural | DVD |
Primary outcome
Brief infant sleep questionnaire
Time frame: 3 weeks
infant sleep patterns and sleep problems
2 secondary outcomes
Profile of mood states
Time frame: 1 week
Pittsburgh sleep quality index
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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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.
Mark Splaingard, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet and DVD in people with Insomnia, run by Nationwide Children's Hospital at 1 site 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 4 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: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Brief infant sleep questionnaire (time frame: 3 weeks). 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 21 Jul 2017.