A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes
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|ClinicalTrials.gov Identifier: NCT03616171|
Recruitment Status : Recruiting
First Posted : August 6, 2018
Last Update Posted : November 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Behavioral: SLEEP-Extend intervention Other: Control||Not Applicable|
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|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective, randomized and unblinded|
|Masking:||None (Open Label)|
|Official Title:||A Sleep Intervention (SLEEP-Extend) for Young Adults At-Risk for Type 2 Diabetes|
|Actual Study Start Date :||October 31, 2018|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||September 2019|
Experimental: Interventional Group
Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:
Behavioral: SLEEP-Extend intervention
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)
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)
- Feasibility of the Study measured by number of enrollments in the study over 1 year [ Time Frame: Up to 12 months ]Feasibility of the study is assessed by number of enrollments in the study over 1 year. Study proposes to enroll minimum 20 subjects to meet the feasibility of the study.
- Feasibility of the SLEEP-Extend intervention among young adults measured by number of subjects enrolled in the intervention arm and complete the study [ Time Frame: Up to 4 weeks ]Feasibility of the SLEEP-Extend intervention among young adults is measured by number of subjects enrolled in the intervention arm that received the intervention and completed the study required protocols for the study duration of 4 weeks.
- Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) scores among the SLEEP-Extend intervention group compared to control group [ Time Frame: Baseline, 4 weeks ]The HOMA-IR is used to measure severity of insulin resistance, though normal insulin resistance varies depending on the population. Common reference levels for HOMA-IR insulin resistance range from 0.7 - 2.
- Change in Sleep Extension among the subjects that received SLEEP-Extend intervention [ Time Frame: Baseline, 4 weeks ]Change in sleep extension is assessed by the percentage of subjects that received intervention and were able to extend their sleep from 1-2 hrs
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616171
|Contact: Ashley Coombe, PhD, RN, CNEemail@example.com|
|United States, Georgia|
|Atlanta, Georgia, United States, 30322|
|Contact: Ashley Coombe, PhD, RN, CNE 404-712-9313 firstname.lastname@example.org|
|Principal Investigator:||Ashley Coombe, PhD, RN, CNE||Emory University|