A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - 25
Updated:11/7/2018
Start Date:October 31, 2018
End Date:September 2019
Contact:Ashley Coombe, PhD, RN, CNE
Email:ashley.coombe@emory.edu
Phone:404-712-9313

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The study is a prospective unblinded randomized trial to evaluate the feasibility of
conducting a sleep extension intervention trial and the sleep extension intervention among
the young adults. The study also wants to assess whether a sleep-extension intervention has
an impact on the insulin resistance levels of young adults. The intervention consists of an
education session and to extend the sleep time at least one hour but can be up to 2 hours per
night for 4 weeks.

Insulin Resistance has been shown to put a person at risk for developing Type II diabetes.
There is a correlation between sleep deprivation and insulin resistance.The study wants to
assess the feasibility by enrolling 20 subjects in a year. The study also wants to assess the
feasibility of the sleep extension intervention among young adults by examining the number of
subjects that are randomized to intervention arm will complete the study.

Another intent of the study is to examine how sleep behaviors affect risks for developing
type 2 diabetes and to determine their willingness to participate in a 4-week home-based
program (intervention) focused on personal sleep behaviors.

Subjects enrolled in the study and are randomized to intervention group and control group.
The intervention group will receive one education session consisting of strategies for sleep
hygiene which is the routine for going to sleep and instructions on extending time in bed by
at least one hour but can be up to 2 hours total per night for 4 weeks. At the end of 4 weeks
subjects will have a blood draw and will complete the questionnaires.

Inclusion Criteria:

- Age must be 18-25 years old

- Subject has the ability to read and write English

- Baseline HOMA-IR of ≥ 2.1

- Short sleep duration of < 6 hours/night (as measured by actigraphy for 7 days)

- BMI (kg/m2) of 25 or more

- Asking if they are willing to participate in a 4-week program focusing on sleep
behavior

- Administration of the Insomnia Severity Index (valid and reliable) to determine sleep
quality (Inclusion criteria includes good quality sleep and is total score of < 15)

Exclusion Criteria:

- Oxygen desaturation index ≥ 5/hour (as measured by 2 nights of pulse oximetry)

- Night shift worker;

- Sleep disorder diagnosis;

- Medical diagnosis of diabetes or pre-diabetes;

- Currently pregnant or lactating or with history of gestational diabetes;

- Actively participating in a weight loss program;

- Hospitalization in past 3 months for any medical or psychiatric condition;

- Having a major chronic illness (e.g. cancer, Lupus)]
We found this trial at
1
site
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Phone: 404-712-9313
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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