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Impact of Sleep Extension in Adolescents (SUNRISE)

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ClinicalTrials.gov Identifier: NCT03500458
Recruitment Status : Recruiting
First Posted : April 18, 2018
Last Update Posted : October 13, 2021
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Colorado, Denver

Brief Summary:
Many teenagers do not get enough sleep. Obesity and diabetes are increasing in teenagers as well. This study plans to learn more about sleep and insulin resistance (insulin not working) in teenagers, and how these things may be related depending on sleep. This is important to know so that the investigators understand how sleep may play a role in health conditions like extra weight gain (increased food intake and less physical activity) and diabetes. To answer this question, the investigators plan to enroll teenagers who get <7 hours of sleep on school nights and measure changes in insulin sensitivity and dietary intake after a week of typical sleep (sleeping on their normal school schedule) and a week of longer sleep (spending 1+ hour longer in bed each night).

Condition or disease Intervention/treatment Phase
Insulin Sensitivity Sleep Dietary Habits Behavioral: Sleep Extension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : December 15, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
No Intervention: Typical Sleep
All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.
Experimental: Sleep Extension
Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep.
Behavioral: Sleep Extension
Participants will be asked to increase time in bed at least 1 hour more than baseline




Primary Outcome Measures :
  1. Change in Insulin Sensitivity [ Time Frame: 2 weeks after Baseline and 7 weeks after Baseline ]
    Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.

  2. Change in Sleep Duration & Timing [ Time Frame: At Baseline, 1 week after Baseline, and 6 weeks after Baseline ]
    Assessed three times with a wrist-worn Actigraphy

  3. Change in Physical activity [ Time Frame: At Baseline, 1 week after Baseline and 6 weeks after Baseline ]
    Assessed three times with a triaxial thigh-worn ActivPal

  4. Change in Dietary Intake [ Time Frame: 1 week after Baseline and 6 weeks after Baseline ]
    Participants will be asked to complete diet diaries two times for 3 days during each sleep condition (prior to each overnight assessment), listing all food and drink consumed, estimated portion size, and timing of consumption.



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Ages Eligible for Study:   14 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. High school students between the age of 14-19 years
  2. have typically insufficient sleep, defined by ≤ 7 hours per night on school days
  3. BMI 5th-84th percentile for age and sex
  4. habitually sedentary (< 3 hours of regular physical activity per week)
  5. Tanner stage 4 or 5, based on breast development for girls and testicular size for boys.

Exclusion Criteria:

  1. Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids)
  2. regular use of melatonin or other sleep aids
  3. a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea)
  4. Type 2 diabetes or prediabetes
  5. IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes)
  6. teens not enrolled in a traditional high school academic program (e.g., home school students)
  7. schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment)
  8. travel across more than two time zones in the 2 weeks prior to the study.

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): NCT03500458


Contacts
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Contact: Stacey Simon, PhD 720-777-5681 stacey.simon@childrenscolorado.org

Locations
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United States, Colorado
Children's Hospital Colorado Recruiting
Aurora, Colorado, United States, 80045
Contact: Karissa Valente    720-777-8486    karissa.valente@childrenscolorado.org   
Sponsors and Collaborators
University of Colorado, Denver
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
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Principal Investigator: Stacey Simon, PhD Children's Hospital Colorado and University of Colorado Anschutz Medical Campus
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Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03500458    
Other Study ID Numbers: 17-2095
K23DK117021 ( U.S. NIH Grant/Contract )
First Posted: April 18, 2018    Key Record Dates
Last Update Posted: October 13, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Insulin Resistance
Hypersensitivity
Immune System Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases