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Completed

NCT Number: NCT01739712

Sleep Intervention for Youth With Type 1 Diabetes

Sleep intervention for youth with diabetes

Completed

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Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Angel Wing Clinic for Diabetes

Tucson, Arizona, 85719, United States

About this study

It is known that sleep disturbances in healthy youth have negative effects on neurobehavioral functioning. Further, data support that individuals with diabetes have more sleep disturbances and compromised neurobehavioral functioning than individuals without diabetes. However, the joint impact of sleep and glucose on neurobehavioral functioning in youth with type 1 diabetes (T1DM) is not yet known. Therefore, our primary study aims are to: (1) determine the relative contributions of various sleep disturbances on glucose control in youth with T1DM; (2) examine the joint impact of glucose control and sleep disturbances on neurobehavioral outcomes in youth with T1DM; and (3) determine if increasing sleep duration relative to youth's typical schedules contributes to changes in glycemic control and neurobehavioral performance. These aims will be achieved by following 120 youth with T1DM ages 10 through 16 for six days of naturalistic sleep using polysomnography, actigraphy, and questionnaires to assess sleep; continuous glucose monitors and hemoglobin A1C values to assess glucose control; and standardized cognitive tasks and behavior rating scales to assess neurobehavioral functioning. Further, the proposed study is innovative in that it will extend existing research by moving from correlational findings to an experimental paradigm by randomizing youth with T1DM to either a Sleep Extension or Fixed Sleep Duration condition for an additional six days. Once our aims are achieved and a causal link is established, the proposed Sleep Extension intervention will advance knowledge about the role of sleep in diabetes management and provide a beneficial intervention to help youth with T1DM.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of type 1 diabetes
  • enrolled in school

Exclusion criteria

  • not hospitalized within past month
  • neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation

Treatment and study plan

Sleep Extension

Behavioral

There will be a consultation with families to help youth to be successful in extending their sleep.

Fixed Sleep Duration

Behavioral

There will be a consultation with families to instruct youth to maintain the same average nightly sleep duration during the modification week. The purpose is to control for time and attention.

Primary outcomes

  1. Academic Rating Scale

    Time frame: 2 weeks

    A teacher behavioral rating of classroom behaviors and performance

  2. Glucose control

    Time frame: 2 weeks

    Continuous glucose monitor

  3. Neurocognitive performance

    Time frame: 2 weeks

    Cogstate learning and memory tasks

  4. Academic performance

    Time frame: 2 weeks

    Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Registry information

Official study title

Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2012
Registry last updated
Nov 21, 2016

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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