Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Type 1 Diabetes Mellitus Clinical Trial

Official title:

Pilot Sleep Intervention to Improve Diabetes Management in School-Aged Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03397147
• Other study ID #: 171902
• Status: Completed
• Phase: N/A
• Start date: July 5, 2018
• Est. completion date: July 9, 2019

Study information

• Verified date: March 2020
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the feasibility, acceptability, and preliminary efficacy of a sleep-promoting intervention for school-aged children with type 1 diabetes and their caregivers in a pilot randomized trial. The primary outcome is improvements in child sleep, and secondary outcomes include glycemic control (HbA1c, % in range), improvements in parent sleep, parental distress, and child behavior problems.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 9, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 9 Years

Eligibility

Inclusion Criteria:

• child between 5-9 years of age

• child have been diagnosed with type 1 diabetes for at least 12 months

• caregiver lives with child

• caregiver can read/speak English

Exclusion Criteria:

• child has other major health problems or sleep disorders other than insufficient sleep or insomnia

• participating in other intervention studies

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Sleep Coach Jr.
A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Sleep Duration	Child sleep duration (measured with actigraphy)	3 months
Primary	Child Sleep Quality	Child sleep quality (measured with Child Sleep Habits Questionnaire)	3 months
Secondary	Glycemic Control	HbA1c, % glucose values in range	3 months
Secondary	Parent Sleep Duration	Parent sleep duration (measured with actigraphy)	3 months
Secondary	Parental Well-being	Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)	3 months
Secondary	Child Behavior Problems	Behavior problems measured with the Child Behavior Checklist (CBCL)	3 months
Secondary	Parent Sleep Quality	and sleep quality (measured with Pittsburgh Sleep Quality Index)	3 months
Secondary	Parental Fear of Hypoglycemia	Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)	3 months
Secondary	Parental Diabetes Distress	Diabetes distress (Problem Area In Diabetes - Parental Version Revised)	3 months