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

Emory University

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: SLEEP-Extend intervention; Other: Control

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03616171

IRB00105390

5P30DK111024-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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6 participants in 2 patient groups

Interventional Group

Experimental group

Description:

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).

Treatment:

Behavioral: SLEEP-Extend intervention

Control Group

Other group

Description:

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)

Treatment:

Other: Control