RECRUITING

Biomarkers of Increased Free Living Sleep Time

Conditions

Sleep Deprivation Insufficient Sleep Syndrome Sleep Wake Disorders

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This protocol will increase sleep duration in participants who maintain less than 6 hours sleep per night, to target the recommended 7 hours of sleep per night. The focus of this study is determine how increasing nightly sleep duration in these individuals who maintain less than 6 hours sleep per night changes their plasma metabolome and insulin sensitivity. The primary outcome will examine changes in branched-chain amino acids and the secondary outcome will examine changes in insulin sensitivity. The investigators will also determine if changes in plasma metabolites can be used as a biomarker to discriminate between adequate versus insufficient sleep.

Official Title

Biomarkers and Altered Metabolic Pathways During Sleep Loss

Quick Facts

Study Start:2019-12-02

Study Completion:2024-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04214184

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 35 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
1. 18-35 years old; men and women 2. Body Mass Index (BMI) of \> 18.5 and \<24.9. 3. Inactive to habitual moderate physical activity level (\<5 days of exercise per week). 4. Sleep/wake history: habitual sleep duration less than 6 hours per night. 5. Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.	1. Any clinically significant unstable medical or surgical condition within the last year (treated or untreated). 2. Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I 3. Any clinically significant sleep disorder. 4. Use of prescription medications/supplements within one month or need of these medications at any time during the study. 5. Symptoms of active illness (e.g., fever). 6. Uncorrected visual impairment 7. History of shift work in prior year or travel more than one time zone in three weeks prior to study. 8. Participants must be entirely drug-free of illicit drugs, medications, nicotine and herbal products for one month prior to study. 9. Blood donation in the 30 days prior to inpatient study. 10. Ovulating women will be selected on the basis of a history of regular menstrual cycle ranging in length from 25-32 days with a maximum of three days variation month-to-month. They will have no history of prior gynecological pathology, be at least 1 year post-partum, not breast-feeding and not pregnant (HCG pregnancy test at screening and upon admission to the inpatient protocol).

Inclusion Criteria

Exclusion Criteria

1. 18-35 years old; men and women
2. Body Mass Index (BMI) of \> 18.5 and \<24.9.
3. Inactive to habitual moderate physical activity level (\<5 days of exercise per week).
4. Sleep/wake history: habitual sleep duration less than 6 hours per night.
5. Altitude history: Potential participants must have lived at Denver altitude or higher for at least 3 months.

1. Any clinically significant unstable medical or surgical condition within the last year (treated or untreated).
2. Any clinically significant psychiatric condition, as defined by DSM-IV-TR. I
3. Any clinically significant sleep disorder.
4. Use of prescription medications/supplements within one month or need of these medications at any time during the study.
5. Symptoms of active illness (e.g., fever).
6. Uncorrected visual impairment
7. History of shift work in prior year or travel more than one time zone in three weeks prior to study.
8. Participants must be entirely drug-free of illicit drugs, medications, nicotine and herbal products for one month prior to study.
9. Blood donation in the 30 days prior to inpatient study.
10. Ovulating women will be selected on the basis of a history of regular menstrual cycle ranging in length from 25-32 days with a maximum of three days variation month-to-month. They will have no history of prior gynecological pathology, be at least 1 year post-partum, not breast-feeding and not pregnant (HCG pregnancy test at screening and upon admission to the inpatient protocol).

Contacts and Locations

Study Contact

Christopher Depner

CONTACT

303-735-1923

christopher.depner@utah.edu

Principal Investigator

Christopher Depner

PRINCIPAL_INVESTIGATOR

University of Utah

Study Locations (Sites)

Sleep Wake Center--University of Utah

Salt Lake City, Utah, 84108

United States

Collaborators and Investigators

Sponsor: University of Utah

Christopher Depner, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-02

Study Completion Date2024-07-31

Study Record Updates

Study Start Date2019-12-02

Study Completion Date2024-07-31

Terms related to this study

Additional Relevant MeSH Terms

Sleep Deprivation
Insufficient Sleep Syndrome
Sleep Wake Disorders