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Trial record 17 of 95 for:    Recruiting, Not yet recruiting, Available Studies | diabetes | NIDDK | ( Map: United States )

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
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Ashley Coombe, 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Behavioral: SLEEP-Extend intervention Other: Control Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized and unblinded
Masking: None (Open Label)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interventional Group

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).
Behavioral: SLEEP-Extend intervention
  1. One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep
  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

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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)]

Information from the National Library of Medicine

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


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

Locations
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United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Ashley Coombe, PhD, RN, CNE    404-712-9313    ashley.coombe@emory.edu   
Sponsors and Collaborators
Emory University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Ashley Coombe, PhD, RN, CNE Emory University

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Responsible Party: Ashley Coombe, Assistant Clinical Professor, Emory University
ClinicalTrials.gov Identifier: NCT03616171     History of Changes
Other Study ID Numbers: IRB00105390
5P30DK111024-02 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: November 5, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ashley Coombe, Emory University:
Sleep Behavior
Insulin resistance

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases