Sleep Intervention for Youth With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01739712
• Other study ID #: 12-0733091
• Status: Completed
• Phase: N/A
• First received: November 29, 2012
• Last updated: November 17, 2016
• Start date: October 2012
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Sleep intervention for youth with diabetes

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 16 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Behavioral:
• Sleep extension
There will be a consultation with families to help youth to be successful in extending their sleep.
• Fixed Sleep Duration
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.

Locations

Country	Name	City	State
United States	Angel Wing Clinic for Diabetes	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Academic Rating Scale	A teacher behavioral rating of classroom behaviors and performance	2 weeks	No
Primary	Glucose control	Continuous glucose monitor	2 weeks	No
Primary	Neurocognitive performance	Cogstate learning and memory tasks	2 weeks	No
Primary	Academic performance	Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements	2 weeks	No