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Sleep Intervention for Youth With Type 1 Diabetes

NCT ID: NCT01739712

Last Updated: 2016-11-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2016-08-31

Brief Summary

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Sleep intervention for youth with diabetes

Detailed Description

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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.

Conditions

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Diabetes

Keywords

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Diabetes Sleep problems School Neurobehavioral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Sleep Extension

All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer

Group Type EXPERIMENTAL

Sleep extension

Intervention Type BEHAVIORAL

There will be a consultation with families to help youth to be successful in extending their sleep.

Fixed Sleep Duration

All youth in this condition are asked to maintain their baseline sleep duration.

Group Type SHAM_COMPARATOR

Fixed Sleep Duration

Intervention Type BEHAVIORAL

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.

Interventions

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Sleep extension

There will be a consultation with families to help youth to be successful in extending their sleep.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Arizona

OTHER

Sponsor Role lead

Responsible Party

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Michelle Perfect

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michelle M Perfect, PhD

Role: PRINCIPAL_INVESTIGATOR

UA College of Education

Locations

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Angel Wing Clinic for Diabetes

Tucson, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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12-0733091

Identifier Type: -

Identifier Source: org_study_id