Impact of Sleep Extension in Adolescents

NCT ID: NCT03500458

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-15
• Study Completion Date: 2025-05-31

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).

Conditions

Insulin Sensitivity; Sleep; Dietary Habits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Typical Sleep

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Sleep Extension

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).

Group Type: EXPERIMENTAL

Sleep Extension

Intervention Type: BEHAVIORAL

Participants will be asked to increase time in bed at least 1 hour more than baseline

Interventions

Sleep Extension

Participants will be asked to increase time in bed at least 1 hour more than baseline

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stacey Simon, PhD

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Colorado and University of Colorado Anschutz Medical Campus

Locations

Children's Hospital Colorado

Aurora, Colorado, United States

Countries

United States

Other Identifiers

K23DK117021

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R03DK131225

Identifier Type: NIH

Identifier Source: secondary_id

View Link

17-2095

Identifier Type: -

Identifier Source: org_study_id