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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Other: Control; Behavioral: SLEEP-Extend intervention

• Registration Number: NCT03616171
• Lead Sponsor: Emory University

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-08-30
• Primary Completion: 2018-04-02
• Study Completion: 2018-04-02
• Study First Submitted: 2018-07-23
• Study First Submitted QC: 2018-07-31
• Study First Posted: 2018-08-06
• Results First Submitted: 2019-11-22
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-12
• Last Update Submitted: 2019-12-12
• Results First Posted: 2019-12-30
• Last Update Posted: 2019-12-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Control	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)
Interventional Group	SLEEP-Extend intervention	Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components: 1. 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) 2. 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).

Primary Outcome Measures

Name	Time	Method
Number of Enrollments in the Study Over One Year	Up to 12 months	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.
Number of Participants Enrolled in the Intervention Arm Who Complete the Study	Week 4	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.

Secondary Outcome Measures

Name	Time	Method
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) Scores	Baseline, Week 4	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.
Hours of Sleep	Over a 1 week period at Baseline, and over a 1 week period at Week 4	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.
Number of Participants Extending Sleep	Over a 1 week period at Baseline, and over a 1 week period at Week 4	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.

Trial Locations

Locations (2)

Georgia State University; 🇺🇸 Atlanta, Georgia, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States