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Sleep Intervention for Youth With Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by University of Arizona
Sponsor:
Information provided by (Responsible Party):
Michelle Perfect, University of Arizona
ClinicalTrials.gov Identifier:
NCT01739712
First received: November 29, 2012
Last updated: April 27, 2016
Last verified: April 2016
  Purpose
Sleep intervention for youth with diabetes

Condition Intervention
Diabetes
Behavioral: Sleep extension
Behavioral: Fixed Sleep Duration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement

Resource links provided by NLM:


Further study details as provided by University of Arizona:

Primary Outcome Measures:
  • Academic Rating Scale [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    A teacher behavioral rating of classroom behaviors and performance

  • Glucose control [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Continuous glucose monitor

  • Neurocognitive performance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Cogstate learning and memory tasks

  • Academic performance [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
    Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   10 Years to 16 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01739712

Contacts
Contact: Michelle M Perfect, PhD 520-626-1128 mperfect@email.arizona.edu

Locations
United States, Arizona
Angel Wing Clinic for Diabetes Recruiting
Tucson, Arizona, United States, 85719
Principal Investigator: Michelle M Perfect, Ph.D.         
Sub-Investigator: Mark Wheeler, MD         
Sponsors and Collaborators
University of Arizona
Investigators
Principal Investigator: Michelle M Perfect, PhD UA College of Education
  More Information

Responsible Party: Michelle Perfect, Associate Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT01739712     History of Changes
Other Study ID Numbers: 12-0733091 
Study First Received: November 29, 2012
Last Updated: April 27, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Upon request.

Keywords provided by University of Arizona:
Diabetes
Sleep problems
School
Neurobehavioral

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 23, 2016