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Sleep Intervention for Youth With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01739712
Recruitment Status : Completed
First Posted : December 3, 2012
Last Update Posted : November 21, 2016
Information provided by (Responsible Party):
Michelle Perfect, University of Arizona

Brief Summary:
Sleep intervention for youth with diabetes

Condition or disease Intervention/treatment Phase
Diabetes Behavioral: Sleep extension Behavioral: Fixed Sleep Duration Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement
Study Start Date : October 2012
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Sleep Extension
All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer
Behavioral: Sleep extension
There will be a consultation with families to help youth to be successful in extending their sleep.

Sham Comparator: Fixed Sleep Duration
All youth in this condition are asked to maintain their baseline sleep duration.
Behavioral: 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.

Primary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01739712

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United States, Arizona
Angel Wing Clinic for Diabetes
Tucson, Arizona, United States, 85719
Sponsors and Collaborators
University of Arizona
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Principal Investigator: Michelle M Perfect, PhD UA College of Education

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Responsible Party: Michelle Perfect, Associate Professor, University of Arizona Identifier: NCT01739712    
Other Study ID Numbers: 12-0733091
First Posted: December 3, 2012    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon request.
Keywords provided by Michelle Perfect, University of Arizona:
Sleep problems
Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases