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NCT05370339 Clinical Trial

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

Type 1 Diabetes Clinical Trial

Official title:
Assessment of Sleep and Sleep Disruptors in Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05370339
Other study ID # 21-4311
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 15, 2022
Est. completion date August 30, 2023

Study information
Verified date September 2023
Source University of Colorado, Denver
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 11 Years to 17 Years
Eligibility Inclusion Criteria: - Diagnosed with T1D at least 3 months - Receive clinical care at the Barbara Davis Center 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Colorado, Barbara Davis Center Aurora Colorado

Sponsors (3)
Lead Sponsor Collaborator
University of Colorado, Denver Juvenile Diabetes Research Foundation, The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of nocturnal awakenings per week 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. One week per participant
Primary Assessment of facilitators and barriers to good sleep quality and duration 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. One week per participant
Secondary Identification of common causes of sleep disruptors in adolescents with type 1 diabetes Sleep diaries will be used to determine common causes of sleep disruptors in adolescents with type 1 diabetes. One week per participant
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