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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05370339

Enrollment

Registered

2022-05-11

Start date

2022-06-15

Completion date

2023-08-30

Last updated

2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insufficient Sleep, Type 1 Diabetes

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

11 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results