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

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 Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Behavioral: SLEEP-Extend intervention; Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Georgia State University
    • Atlanta, Georgia, United States, 30322
      • Emory University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age must be 18-25 years old
• Self-report short sleep
• BMI ≥ 30 (the World Health Organization's classification of being obese)
• Insulin Resistance determined by serum analysis
• Be willing to extend time in bed by one hour total per night
• Read and speak English.

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional Group; Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components: One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep (an investigator-developed brochure and information based on recommendations from the American Academy of Sleep Medicine and the National Sleep Foundation will be given and reviewed with the subject); Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later (subject will decide what works best for them).	Behavioral: SLEEP-Extend intervention; One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep; Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later
Other: Control Group; Control group: consists of One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)	Other: Control; Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Enrollments in the Study Over One Year	Feasibility of the study is assessed by number of enrollments in the study over a one year period. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.	Up to 12 months
Number of Participants Enrolled in the Intervention Arm Who Complete the Study	Feasibility of the SLEEP-Extend intervention among young adults is measured by number of participants enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores	The HOMA-IR score is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. HOMA-IR is calculated as blood glucose level (nmol/L) multiplied by insulin level (microU/L), divided by 22.5. Elevated values indicate insulin resistance. A cutoff score of HOMA-IR < 2.1 is considered normal and HOMA-IR ≥ 2.1 is considered to be evidence of insulin resistance.	Baseline, Week 4
Hours of Sleep	Using wrist actigraphy, this study will objectively monitor each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.	Over a 1 week period at Baseline, and over a 1 week period at Week 4
Number of Participants Extending Sleep	Sleep extension is assessed as the number of participants extending their nightly sleep by 1 to 2 hours from the baseline visit to the week 4 visit, as monitored using wrist actigraphy to measure each participant's 24-hour sleep-wake cycle to obtain average sleep duration (total sleep time) over one week.	Over a 1 week period at Baseline, and over a 1 week period at Week 4

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Ashley Coombe, PhD, RN, CNE, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2017
• Primary Completion (Actual): April 2, 2018
• Study Completion (Actual): April 2, 2018

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: July 31, 2018
• First Posted (Actual): August 6, 2018

Study Record Updates

• Last Update Posted (Actual): December 30, 2019
• Last Update Submitted That Met QC Criteria: December 12, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Insulin resistance; Sleep Behavior
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: IRB00105390; 5P30DK111024-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No