Sleep Intervention for Youth With Type 1 Diabetes
November 17, 2016 updated by: Michelle Perfect, University of Arizona
Students With Diabetes: Does Optimizing Sleep Promote Classroom, Behavioral, and Disease-Related Improvement
Sleep intervention for youth with diabetes
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
114
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Arizona
-
Tucson, Arizona, United States, 85719
- Angel Wing Clinic for Diabetes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / 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
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Academic Rating Scale
Time Frame: 2 weeks
|
A teacher behavioral rating of classroom behaviors and performance
|
2 weeks
|
|
Glucose control
Time Frame: 2 weeks
|
Continuous glucose monitor
|
2 weeks
|
|
Neurocognitive performance
Time Frame: 2 weeks
|
Cogstate learning and memory tasks
|
2 weeks
|
|
Academic performance
Time Frame: 2 weeks
|
Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Michelle M Perfect, PhD, UA College of Education
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
November 29, 2012
First Submitted That Met QC Criteria
November 29, 2012
First Posted (Estimate)
December 3, 2012
Study Record Updates
Last Update Posted (Estimate)
November 21, 2016
Last Update Submitted That Met QC Criteria
November 17, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-0733091
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Upon request.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.