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Clinical Trials/NCT05370339
NCT05370339CompletedNot Applicable

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

University of Colorado, Denver1 site in 1 country70 target enrollmentStarted: June 15, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
70
Locations
1
Primary Endpoint
Number of nocturnal awakenings per week

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
11 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Number of nocturnal awakenings per week

Time Frame: 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

Time Frame: 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 Outcomes

  • Identification of common causes of sleep disruptors in adolescents with type 1 diabetes(One week per participant)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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