Sleep Intervention for Youth With Type 1 Diabetes

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2012 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: NA
Last verified: November 2012
History: No changes posted
  Purpose

Sleep interventin for youth with diabetes


Condition Intervention
Diabetes
Behavioral: Sleep extension

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
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: 15
Study Start Date: October 2012
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sleep Extension
All youth with be 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.

  Eligibility

Ages Eligible for Study:   10 Years to 16 Years
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 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
  More Information

No publications provided

Responsible Party: Michelle Perfect, Assistant 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: November 29, 2012
Health Authority: United States: Institutional Review Board

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 August 26, 2014