NCT01739712

Brief Summary

Sleep intervention for youth with diabetes

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2012

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

3.8 years

First QC Date

November 29, 2012

Last Update Submit

November 17, 2016

Conditions

Diabetes

Keywords

DiabetesSleep problemsSchoolNeurobehavioral

Outcome Measures

Primary Outcomes (4)

  • Academic Rating Scale

    A teacher behavioral rating of classroom behaviors and performance

    2 weeks

  • Glucose control

    Continuous glucose monitor

    2 weeks

  • Neurocognitive performance

    Cogstate learning and memory tasks

    2 weeks

  • Academic performance

    Woodcock Johnson Tests of Achievement-3rd Edition NU and Curriculum-Based Measurements

    2 weeks

Study Arms (2)

Sleep Extension

EXPERIMENTAL

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

Fixed Sleep Duration

SHAM COMPARATOR

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

Behavioral: Fixed Sleep Duration

Interventions

Sleep extensionBEHAVIORAL

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

Sleep Extension
Fixed Sleep DurationBEHAVIORAL

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.

Fixed Sleep Duration

Eligibility Criteria

Age10 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • diagnosis of type 1 diabetes
  • enrolled in school

You may not qualify if:

  • not hospitalized within past month
  • neurological, developmental, or psychiatric condition that in the opinion of the PI would significantly interfere with sleep or participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Angel Wing Clinic for Diabetes

Tucson, Arizona, 85719, United States

Location

MeSH Terms

Conditions

Diabetes MellitusParasomnias

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Michelle M Perfect, PhD

    UA College of Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 29, 2012

First Posted

December 3, 2012

Study Start

October 1, 2012

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will share

Upon request.

Locations

US(1)