Increasing Childhood Sleep Duration in the Primary Care Setting

Sleep Clinical Trial

Official title:

Increasing Childhood Sleep Duration in the Primary Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03870282
• Other study ID #: 18-015830
• Status: Completed
• Phase: N/A
• Start date: February 21, 2019
• Est. completion date: January 3, 2021

Study information

• Verified date: March 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Investigators seek to determine if a mobile health based intervention can be developed to target increases in childhood sleep duration.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: January 3, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 12 Years

Eligibility

Inclusion Criteria:

1. Males or females age 9 to 12 years.

2. Speak, read and write in English.

3. Parental/guardian permission (informed consent) and child assent.

4. Have a computer or a tablet computer with access to the Internet, or own a smartphone with a data and text plan.

5. 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).

Exclusion Criteria:

1. Any clinically diagnosed sleep disorder (e.g. sleep apnea).

2. Diagnosed with a psychiatric disorder [e.g. attention deficit hyperactivity disorder (ADHD), depression, anxiety].

3. Diagnosed with an eating disorder.

4. Musculoskeletal or neurological disorder that limits physical movement and activity.

5. Use of medications (prescription or otherwise) known to affect body weight and/or sleep.

Related Conditions & MeSH terms

• Sleep

Intervention

Behavioral:
• Sleep Extension
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.

Locations

Country	Name	City	State
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Actigraphy Estimated Nighttime Sleep Duration	The investigators' other outcomes are actigraphy estimated nighttime sleep duration operationalized as the average hours per night per week.	10 weeks
Other	Actigraphy Estimated Weekend Night Sleep Duration	The investigators' other outcomes are actigraphy estimated weekend night sleep duration operationalized as the average hours per weekend night per week.	10 weeks
Other	Actigraphy Estimated Sleep Efficiency (Nighttime, Weeknight and Weekend Night)	The investigators' other outcomes are actigraphy estimated sleep efficiency per night, weeknight, and weekend night operationalized as percentage of time spent asleep during the overnight sleep period.	10 weeks
Primary	Actigraphy Estimated Weeknight Sleep Duration	The investigators' primary outcome is actigraphy estimated weeknight sleep duration operationalized as the average hours per weeknight per week.	10 weeks
Secondary	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.	15 minutes
Secondary	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.	15 minutes