Sleep, Coping and Executive Functioning in Youth With Type 1 Diabetes (SleepT1D)
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|ClinicalTrials.gov Identifier: NCT02908555|
Recruitment Status : Completed
First Posted : September 21, 2016
Last Update Posted : July 2, 2018
The purpose of this exploratory study is to evaluate the characteristics of sleep, perceptions of barriers and facilitators to adequate sleep, and the associations among sleep characteristics, executive functioning, coping, adherence, 24-hour glucose levels, and adjustment in adolescents with type 1 diabetes. A mixed methods approach that includes a quantitative component, consisting of actigraphy and sleep diaries, questionnaires, tests of executive function and continuous glucose monitoring (CGM) as well as a narrative qualitative component will be used. Results from this pilot study will be used to provide the effect sizes needed for a larger-scale descriptive study and to establish the need for a possible sleep-promoting intervention for adolescents with type 1 diabetes. This project is consistent with ongoing research focused on developing preventive, behavioral interventions for youth with type 1 diabetes and their families to improve physiological (i.e., glycemic control) and psychological (i.e., quality of life) outcomes. Sleep promotion may become an important component of these interventions. Thus, the following specific aims will be addressed:
- Describe the objective and subjective characteristics of sleep (duration, continuity, bed time/rise times); sleep quality and sleep habits among adolescents with type 1 diabetes.
- Explore the relationship between characteristics of self-reported sleep (i.e., habits, duration, daytime sleepiness) and executive function, coping, adherence, and adjustment (i.e., depressive symptoms, quality of life) in adolescents with type 1 diabetes.
- Explore the relationship of glucose excursions on sleep characteristics and executive functioning.
3. Conduct a qualitative study using narrative analysis with adolescents to identify perceived barriers, facilitators, and consequences associated with insufficient sleep in adolescents with type 1 diabetes.
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 1||Other: No intervention|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||Sleep, Coping, and Executive Functioning in Youth With Type 1 Diabetes|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||June 15, 2018|
|Actual Study Completion Date :||June 15, 2018|
Descriptive study without groups
Other: No intervention
This is a descriptive study with no intervention
- Glycemic control [ Time Frame: baseline ]Hemoglobin A1C
- Executive functioning [ Time Frame: baseline ]Trail Making Test Part B
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02908555
|United States, Connecticut|
|Yale School of Nursing|
|West Haven, Connecticut, United States, 06516-0972|
|Principal Investigator:||Margaret Grey, DrPH||Yale University|