Clinical trial NCT01739712: Sleep Intervention for Youth With Type 1 Diabetes
Official title: Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Sleep problems
School
Neurobehavioral
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2012-12-03
Enrollment: 114
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Academic Rating Scale
timeFrame: 2 weeks
measure: Glucose control
timeFrame: 2 weeks
measure: Neurocognitive performance
timeFrame: 2 weeks
measure: Academic performance
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Angel Wing Clinic for Diabetes
state: Arizona
Study officials:
affiliation: UA College of Education
name: Michelle M Perfect, PhD
role: PRINCIPAL_INVESTIGATOR
References: