Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

Completed

• Conditions: Insufficient Sleep; Type 1 Diabetes

• Registration Number: NCT05370339
• Lead Sponsor: University of Colorado, Denver

Brief Summary

The goal of this study is to identify causes of insufficient sleep and sleep disruptors in adolescents with type 1 diabetes. For this study, adolescents will wear an actigraphy watch and complete sleep diaries for seven days. On completion of the seven days, they will complete several questionnaires regarding sleep, fear of hypoglycemia, and anxiety and depression. A subset of participants will additionally complete a qualitative interview session to obtain a deeper understanding of sleep disruptors and barriers and facilitators to improving sleep health.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-11
• Study Start: 2022-06-15
• Primary Completion: 2023-08-30
• Study Completion: 2023-08-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Diagnosed with T1D at least 3 months
• Receive clinical care at the Barbara Davis Center

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Exclusion Criteria

• Have an active underlying sleep disorder, such as narcolepsy, insomnia, or untreated sleep apnea
• Participation in an interventional research protocol
• Unable to complete study procedures

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of nocturnal awakenings per week	One week per participant	We will identify the number of nocturnal awakenings per week for comparison of those with insufficient sleep identified by actigraphy watch to those with sufficient sleep.
Assessment of facilitators and barriers to good sleep quality and duration	One week per participant	Qualitative interviews will be conducted and analyzed for themes to identify causes of sleep disruptions and any potential barriers or facilitators to improving sleep health.

Secondary Outcome Measures

Name	Time	Method
Identification of common causes of sleep disruptors in adolescents with type 1 diabetes	One week per participant	Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes.

Trial Locations

Locations (1)

University of Colorado, Barbara Davis Center; 🇺🇸 Aurora, Colorado, United States