SleepNCT03870282
Increasing Childhood Sleep Duration in the Primary Care Setting
A study testing Sleep Extension in people with Sleep, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Sleep Extension
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2019to 3 Jan 2021
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Males or females age 9 to 12 years.
- Speak, read and write in English.
- Parental/guardian permission (informed consent) and child assent.
- Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm \& get out of bed at 6am).
Who cannot join
- Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- Diagnosed with a psychiatric disorder [e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety].
- Diagnosed with an eating disorder.
- Musculoskeletal or neurological disorder that limits physical movement and activity.
- Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.
Read the detailed description
Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).
- Conditions
- Sleep
- Being tested
- Sleep Extension
- Keywords
- Childhood sleep promotion, Sleep promotion, Sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep ExtensionBehavioural
The intervention is designed to test if sleep tips delivered by text messages can aid with reaching sleep targets. And if additional motivational text messages can further aide with reaching sleep targets.
| Study group | Role | What they receive |
|---|---|---|
| 9h 15m Goal | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| 9h 15m Goal | Incentives A&B | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Text A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Texts B | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Texts A | Experimental | Not described Receives: Behavioral: Sleep Extension |
| Personal Goal | Incentives A&B | Texts A&B | Experimental | Not described Receives: Behavioral: Sleep Extension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Actigraphy Estimated Weeknight Sleep Duration
The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.
Measured: 10 weeks
Secondary outcomes (2)
Sleep Disturbance Score
Measured using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) 9-item bank for pediatric sleep, ages 8-17y. The sleep disturbance score is calculated by summing responses to items related to sleep onset, sleep continuity and sleep quality. Higher scores for sleep disturbance indicate poorer sleep quality. We will operationalize our secondary outcomes as T-scores, using the standard PROMIS approach.
Measured: 15 minutes
Sleep Related Impairment Score
Measured using the validated Patient-Reported Outcomes Measurement Information System (PROMIS) 9-item bank for pediatric sleep, ages 8-17y. The sleep-related impairment score is calculated by summing responses to items related to daytime sleepiness, cognition, affect \& behavior and daytime activities. Higher scores for sleep impairment indicate poorer sleep quality. We will operationalize our secondary outcomes as T-scores, using the standard PROMIS approach.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start21 Feb 2019
- Primary completion1 Nov 2020
- Study completion3 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- Factorial
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan A Mitchell, PhD, Principal investigator, Childern's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03870282
- Sponsor's protocol ID
- 18-015830
- Status last verified
- Mar 2021
- First submitted
- 8 Mar 2019
- Last updated
- 24 Mar 2021
- Results posted
- 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 24 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing Childhood Sleep Duration in the Primary Care Setting
- ClinicalTrials.gov ID
- NCT03870282
- Acronym / sponsor ID
- 18-015830
- Conditions
- Sleep
- Keywords
- Childhood sleep promotion, Sleep promotion, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- 21 Feb 2019 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 3 Jan 2021 (actual)
- First posted
- 12 Mar 2019 (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.
Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.
Detailed description
Investigators seek to determine if an online based intervention can be developed to target increases in childhood sleep. The primary objectives of this study are to determine if different messaging strategies lead to the longer sleep duration.Children aged 9-12 who sleep about 6-8.5 hours per night will wear a Fitbit for 11 weeks in order to measure sleep patterns. Participants will have a sleep goal to meet each night. Participants will be randomized to one of thirty-two study conditions and receive text and/or email messaging. Some study arms receive additional messaging with different content and frequency of delivery. The study involves one visit to the Children's Hospital of Philadelphia (CHOP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 32
| Arm | Type | Receives |
|---|---|---|
| 9h 15m Goal | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Texts B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Texts A | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Texts A&B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts A | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive B | Texts A&B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts A | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A | Texts A&B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Texts B | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentive A&B | Texts A | Experimental | Behavioral: Sleep Extension |
| 9h 15m Goal | Incentives A&B | Texts A&B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Texts B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Texts A | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Texts A&B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Texts B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Text A | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive B | Texts A&B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts A | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A | Texts A&B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Texts B | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentive A&B | Texts A | Experimental | Behavioral: Sleep Extension |
| Personal Goal | Incentives A&B | Texts A&B | Experimental | Behavioral: Sleep Extension |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females age 9 to 12 years.
- Speak, read and write in English.
- Parental/guardian permission (informed consent) and child assent.
- Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.
- Parent reported time in bed on school nights between 6.0-8.5 hours in bed at night (e.g. 7-hour time in bed: go to bed at 11pm \& get out of bed at 6am).
Key exclusion criteria (5 listed)
- Any clinically diagnosed sleep disorder (e.g. sleep apnea).
- Diagnosed with a psychiatric disorder [e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety].
- Diagnosed with an eating disorder.
- Musculoskeletal or neurological disorder that limits physical movement and activity.
- Use of medications (prescription or otherwise) known to affect body weight and/or sleep.
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 ExtensionThe intervention is designed to test if sleep tips delivered by text messages can aid with reaching sleep targets. And if additional motivational text messages can further aide with reaching sleep targets. | Behavioural | 9h 15m Goal, 9h 15m Goal | Incentive A, 9h 15m Goal | Incentive A | Texts A, 9h 15m Goal | Incentive A | Texts A&B, 9h 15m Goal | Incentive A | Texts B, 9h 15m Goal | Incentive A&B, 9h 15m Goal | Incentive A&B | Texts A, 9h 15m Goal | Incentive A&B | Texts B, 9h 15m Goal | Incentive B, 9h 15m Goal | Incentive B | Texts A, 9h 15m Goal | Incentive B | Texts A&B, 9h 15m Goal | Incentive B | Texts B, 9h 15m Goal | Incentives A&B | Texts A&B, 9h 15m Goal | Texts A, 9h 15m Goal | Texts A&B, 9h 15m Goal | Texts B, Personal Goal, Personal Goal | Incentive A, Personal Goal | Incentive A | Texts A, Personal Goal | Incentive A | Texts A&B, Personal Goal | Incentive A | Texts B, Personal Goal | Incentive A&B, Personal Goal | Incentive A&B | Texts A, Personal Goal | Incentive A&B | Texts B, Personal Goal | Incentive B, Personal Goal | Incentive B | Text A, Personal Goal | Incentive B | Texts A&B, Personal Goal | Incentive B | Texts B, Personal Goal | Incentives A&B | Texts A&B, Personal Goal | Texts A, Personal Goal | Texts A&B, Personal Goal | Texts B |
Primary outcome
Actigraphy Estimated Weeknight Sleep Duration
Time frame: 10 weeks
The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.
2 secondary outcomes
Sleep Disturbance Score
Time frame: 15 minutes
Sleep Related Impairment Score
Time frame: 15 minutes
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 24 Mar 2021.
- 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.
Jonathan A Mitchell, PhD principal investigator
Childern's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Extension in people with Sleep, run by Children's Hospital of Philadelphia 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 5 inclusion and 5 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 24 Mar 2021. 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?
Actigraphy Estimated Weeknight Sleep Duration (time frame: 10 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 24 Mar 2021.