Atlanta, Georgia 30322


Purpose:

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.


Study summary:

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.


Criteria:

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)]


NCT ID:

NCT03616171


Primary Contact:

Principal Investigator
Ashley Coombe, PhD, RN, CNE
Emory University

Ashley Coombe, PhD, RN, CNE
Phone: 404-712-9313
Email: ashley.coombe@emory.edu


Backup Contact:

N/A


Location Contact:

Atlanta, Georgia 30322
United States

Ashley Coombe, PhD, RN, CNE
Phone: 404-712-9313
Email: ashley.coombe@emory.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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