Sleep Intervention for Youth With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Fixed Sleep Duration; Behavioral: Sleep extension

• Registration Number: NCT01739712
• Lead Sponsor: University of Arizona

Brief Summary

Sleep intervention for youth with diabetes

Detailed Description

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-11-29
• Study First Submitted QC: 2012-11-29
• Study First Posted: 2012-12-03
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-17
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 114

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fixed Sleep Duration	Fixed Sleep Duration	All youth in this condition are asked to maintain their baseline sleep duration.
Sleep Extension	Sleep extension	All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

Primary Outcome Measures

Name	Time	Method
Academic performance	2 weeks	Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements
Academic Rating Scale	2 weeks	A teacher behavioral rating of classroom behaviors and performance
Glucose control	2 weeks	Continuous glucose monitor
Neurocognitive performance	2 weeks	Cogstate learning and memory tasks

Trial Locations

Locations (1)

Angel Wing Clinic for Diabetes; 🇺🇸 Tucson, Arizona, United States