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Impact of Sleep Extension in Adolescents (SUNRISE)

Primary Purpose

Insulin Sensitivity, Sleep, Dietary Habits

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sleep Extension
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Sensitivity

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Children's Hospital ColoradoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Typical Sleep

Sleep Extension

Arm Description

All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.

Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation).

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity
Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
Change in Sleep Duration & Timing
Assessed three times with a wrist-worn Actigraphy
Change in Physical activity
Assessed three times with a triaxial thigh-worn ActivPal
Change in Dietary Intake
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.

Secondary Outcome Measures

Change in glycemic variability
Assessed two times with a continuous glucose monitor
MTNR1B rs10830963 SNP
Genotyping will be conducted on saliva samples

Full Information

First Posted
April 9, 2018
Last Updated
September 26, 2023
Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT03500458
Brief Title
Impact of Sleep Extension in Adolescents
Acronym
SUNRISE
Official Title
Impact of Sleep Extension on Insulin Sensitivity and Dietary Intake in Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2018 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Sensitivity, Sleep, Dietary Habits

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Typical Sleep
Arm Type
No Intervention
Arm Description
All participants will sleep for 6 nights (Sunday - Thursday) in the home environment per their usual school schedule.
Arm Title
Sleep Extension
Arm Type
Experimental
Arm Description
Participants will be prescribed a sleep schedule that allows them to obtain 1 hour more time in bed compared to Typical Sleep. For participants completing the study September 2021 and later, they will also be instructed to take exogenous melatonin (500mcg) and maintain dim light conditions 2 hours before bedtime, and use light glasses for 30 minutes in an upright position after waking in the morning (Sleep Extension + Circadian Manipulation).
Intervention Type
Behavioral
Intervention Name(s)
Sleep Extension
Intervention Description
Participants will be asked to increase time in bed at least 1 hour more than baseline
Primary Outcome Measure Information:
Title
Change in Insulin Sensitivity
Description
Insulin sensitivity assessed two times with an insulin-modified intravenous glucose tolerance test.
Time Frame
2 weeks after Baseline and 7 weeks after Baseline
Title
Change in Sleep Duration & Timing
Description
Assessed three times with a wrist-worn Actigraphy
Time Frame
At Baseline, 1 week after Baseline, and 6 weeks after Baseline
Title
Change in Physical activity
Description
Assessed three times with a triaxial thigh-worn ActivPal
Time Frame
At Baseline, 1 week after Baseline and 6 weeks after Baseline
Title
Change in Dietary Intake
Description
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.
Time Frame
1 week after Baseline and 6 weeks after Baseline
Secondary Outcome Measure Information:
Title
Change in glycemic variability
Description
Assessed two times with a continuous glucose monitor
Time Frame
2 weeks after Baseline and 7 weeks after Baseline
Title
MTNR1B rs10830963 SNP
Description
Genotyping will be conducted on saliva samples
Time Frame
2 weeks after Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: High school students between the age of 14-19 years have typically insufficient sleep, defined by ≤ 7 hours per night on school days BMI 5th-84th percentile for age and sex habitually sedentary (< 3 hours of regular physical activity per week) Tanner stage 4 or 5, based on breast development for girls and testicular size for boys. Exclusion Criteria: Any medications that affect IR or sleep (e.g., metformin, stimulants, atypical antipsychotics, current use of oral steroids) regular use of melatonin or other sleep aids a prior diagnosis of a sleep disorder (e.g. insomnia, delayed sleep phase syndrome, obstructive sleep apnea) Type 2 diabetes or prediabetes IQ<70 or severe mental illness that may impact sleep or ability to consent/assent (e.g., schizophrenia, psychotic episodes) teens not enrolled in a traditional high school academic program (e.g., home school students) schedules that would preclude participants from adhering to the sleep manipulation (e.g. night shift employment) travel across more than two time zones in the 2 weeks prior to the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stacey Simon, PhD
Phone
720-777-5681
Email
stacey.simon@childrenscolorado.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stacey Simon, PhD
Organizational Affiliation
Children's Hospital Colorado and University of Colorado Anschutz Medical Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angel Bernard
Phone
720-777-3491
Email
angel.bernard@childrenscolorado.org

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Sleep Extension in Adolescents

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