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| ID | Type | Description | Link |
|---|---|---|---|
| 5P30DK111024-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional Group | Experimental | Intervention Group (SLEEP-Extend intervention): The SLEEP-Extend intervention consists of two components:
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| Control Group | Other | 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) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SLEEP-Extend intervention | Behavioral |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ashley Coombe, PhD, RN, CNE | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgia State University | Atlanta | Georgia | 30303 | United States | ||
| Emory University |
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A total of 19 individuals consented to take part in the study, of which 13 did not meet eligibility criteria during the screening process, resulting in 6 participants who were randomized to a study arm.
Participants were enrolled between August 30, 2017 and April 2, 2018 from Georgia State University in Atlanta, Georgia.
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| ID | Title | Description |
|---|---|---|
| FG000 | SLEEP-Extend Intervention | Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour. |
| FG001 | Control Group | Participants receiving one educational session consisting of safety practices used for an urban environment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | SLEEP-Extend Intervention | Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour. |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Up to 12 months |
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Information on adverse events was collected from the time of consenting to take part in the study throughout the 4 week study duration.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SLEEP-Extend Intervention | Participants receiving one educational session consisting of strategies for sleep hygiene and instruction to increase time in bed by a total of one hour. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ashley Coombe, PhD | Emory University | 404-712-9313 | ashley.coombe@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Apr 29, 2018 | Nov 14, 2019 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 5, 2019 | Nov 22, 2019 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Prospective, randomized and unblinded
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| Control | Other | 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) |
|
| 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 |
| Atlanta |
| Georgia |
| 30322 |
| United States |
Participants receiving one educational session consisting of safety practices used for an urban environment.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Marital Status | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
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| Primary | 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. | Only participants in the intervention arm are included in this analysis. | Posted | Count of Participants | Participants | Week 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | HOMA-IR score | Baseline, Week 4 |
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| Secondary | 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. | Posted | Mean | Standard Deviation | hours | Over a 1 week period at Baseline, and over a 1 week period at Week 4 |
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| Secondary | 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. | Posted | Count of Participants | Participants | Over a 1 week period at Baseline, and over a 1 week period at Week 4 |
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| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | Control Group | Participants receiving one educational session consisting of safety practices used for an urban environment. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D004700 | Endocrine System Diseases |
| D006946 | Hyperinsulinism |