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OpenTrials
Completed

NCT Number: NCT03397147

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sleep Coach Jr.

Behavioral

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.

Primary outcomes

  1. Child Sleep Duration

    Time frame: 3 months

    Child sleep duration (measured with actigraphy)

  2. Child Sleep Quality

    Time frame: 3 months

    Child sleep quality (measured with Child Sleep Habits Questionnaire)

Secondary outcomes

  1. Glycemic Control

    Time frame: 3 months

    HbA1c, % glucose values in range

  2. Parent Sleep Duration

    Time frame: 3 months

    Parent sleep duration (measured with actigraphy)

  3. Parental Well-being

    Time frame: 3 months

    Well-Being Index (World Health Organization Five Well-Being Index, WHO-5)

  4. Child Behavior Problems

    Time frame: 3 months

    Behavior problems measured with the Child Behavior Checklist (CBCL)

  5. Parent Sleep Quality

    Time frame: 3 months

    and sleep quality (measured with Pittsburgh Sleep Quality Index)

  6. Parental Fear of Hypoglycemia

    Time frame: 3 months

    Parental fear of hypoglycemia (Hypoglycemic Fear Survey, Worry subscale)

  7. Parental Diabetes Distress

    Time frame: 3 months

    Diabetes distress (Problem Area In Diabetes - Parental Version Revised)

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 11, 2018
Registry last updated
Mar 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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