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Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction

Primary Purpose

Glucose Intolerance, Sleep Deprivation, Sleep

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artificial Light At Night
Sleep Restriction
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Glucose Intolerance focused on measuring Chronic Sleep Restiction, Artificial Light At Night, Glucose Intolerance, Melatonin, Sleep

Eligibility Criteria

20 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy adults with conventional and regular sleep-wake timing
  • Non-smokers
  • Completion of medical, psychological, and sleep screening tests
  • Able to spend 33 consecutive days/nights in the laboratory
  • Normal color vision

Exclusion Criteria:

  • History of neurological or psychiatric disorder
  • History of sleep disorder or regular use of sleep-promoting medication
  • Current prescription, herbal, or over-the-counter medication use
  • Traveling across 2 or more time zones within past 3 months
  • Donating blood within past 8 weeks
  • Worked night or rotating shift work within past 3 years
  • Hearing impairment, visual impairment
  • History of eye trauma or surgery
  • Drug or alcohol dependency

Sites / Locations

  • Brigham and Women's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Sleep Restriction with Extended Duration Artificial Light at Night (ALAN)

Sleep Restriction without Extended Duration Artificial Light at Night (ALAN)

Arm Description

In the Sleep Restriction Group with Extended Duration Artificial Light At Night (ALAN) first, the sleep episodes will be shortened to 5 hours, centered at the same time as the baseline sleep (with bedtime 2.5 hours later and wake time 2.5 hours earlier).

In the Sleep Restriction group without Extended Duration ALAN, the sleep episodes will be shortened to 5 hours as in the ALAN Condition (centered at the same time as the baseline sleep with bedtime 2.5 hours later and wake time 2.5 hours earlier), but the participant will remain sitting in bed in near darkness (< 1 lux) for the 2.5 hours before and after the 5-hour sleep episode, such that their exposure to room lighting and activity (14 hours/day) will remain similar to that in the Baseline condition.

Outcomes

Primary Outcome Measures

Impairment of Insulin Sensitivity
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (Artificial Light at Night) (LD 19:5) will induce greater impairment of insulin sensitivity (Si), as assessed by an intravenous glucose tolerance test (IVGTT), than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Insulin sensitivity will be assessed via minimal model analysis.
Impairment of Glucose Tolerance
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will induce greater impairment of glucose tolerance than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Glucose tolerance will be calculated as the rate of glucose disposal over the first 20 minutes after glucose administration.
Duration of Nocturnal Melatonin Secretion
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will reduce the duration of nocturnal melatonin secretion as compared to baseline more than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Duration of nocturnal melatonin secretion will be determined by the duration of time at which melatonin levels are above 25% of their nightly peak levels.

Secondary Outcome Measures

Levels of long-chain highly unsaturated triglycerides
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will lead to a greater reduction in the levels of long-chain highly unsaturated triglycerides than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). We will use liquid chromatography-mass spectrometry to detect lipids of interest. We will focus on triglycerides associated with diabetes risk (e.g. TG44:1, TG46:1, etc.)
Proteomic Profile
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will lead to a change in the proteomic profile compared with exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Blood samples will undergo multiplexed proteomic profiling to search for proteins that are reliably increased or decreased following sleep restriction with ALAN compared to sleep restriction without ALAN.

Full Information

First Posted
April 20, 2021
Last Updated
July 25, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04868539
Brief Title
Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction
Official Title
Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
April 30, 2025 (Anticipated)
Study Completion Date
April 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

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
This project is designed to test for the first time whether glucose metabolism is differentially impaired by sleep restriction with and without additional exposure to artificial light at night (ALAN).
Detailed Description
Laboratory studies have shown that sleep restriction to 4-6h per night for durations varying from one to 14 days reduces glucose tolerance in otherwise healthy adults, but the mechanisms by which insufficient sleep impairs glucose metabolism are still unknown. Current theories are based on the premise that the adverse metabolic consequences are caused by reduction in the duration of sleep per se. However, sleep curtailment is typically accompanied by longer exposure to artificial light at night (ALAN), which is an environmental endocrine disrupter that profoundly disrupts circadian rhythms. The investigators have previously reported that acute circadian misalignment induced hyperglycemia comparable to pre-diabetic states in a third of otherwise healthy participants. Since then, the investigators have shown that even when the circadian phase of participants was realigned, prior exposure to 2 ½ weeks of chronic sleep restriction combined with a history of recurrent circadian disruption induced even more deleterious effects on glucose metabolism, in which pancreatic beta cells failed to respond adequately to increased glucose levels. Moreover, both night and rotating shift work (which induce circadian disruption) are associated with increased risk for metabolic problems. Night shifts can lead to acute increases in glucose and insulin levels, although some studies report reduced insulin release in response to meals consumed during the night. Given that circadian disruption has been shown to independently adversely affect metabolism, and exposure to ALAN adversely impacts metabolism in animals, it is important to understand the extent to which circadian disruption contributes to the observed impact of sleep curtailment on metabolism. No previous studies of the metabolic impact of sleep restriction in humans have controlled for this additional exposure to ALAN, thus confounding the effects of sleep restriction with the effects of circadian disruption caused by extended exposure to ALAN.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glucose Intolerance, Sleep Deprivation, Sleep
Keywords
Chronic Sleep Restiction, Artificial Light At Night, Glucose Intolerance, Melatonin, Sleep

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
This study uses a within-subjects randomized crossover design to compare the effects of sleep restriction with and without ALAN on glucose metabolism. The order in which subjects undergo the two sleep interventions will be randomized.
Masking
Participant
Masking Description
The order in which subjects undergo the two sleep interventions will be randomized.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sleep Restriction with Extended Duration Artificial Light at Night (ALAN)
Arm Type
Experimental
Arm Description
In the Sleep Restriction Group with Extended Duration Artificial Light At Night (ALAN) first, the sleep episodes will be shortened to 5 hours, centered at the same time as the baseline sleep (with bedtime 2.5 hours later and wake time 2.5 hours earlier).
Arm Title
Sleep Restriction without Extended Duration Artificial Light at Night (ALAN)
Arm Type
Experimental
Arm Description
In the Sleep Restriction group without Extended Duration ALAN, the sleep episodes will be shortened to 5 hours as in the ALAN Condition (centered at the same time as the baseline sleep with bedtime 2.5 hours later and wake time 2.5 hours earlier), but the participant will remain sitting in bed in near darkness (< 1 lux) for the 2.5 hours before and after the 5-hour sleep episode, such that their exposure to room lighting and activity (14 hours/day) will remain similar to that in the Baseline condition.
Intervention Type
Other
Intervention Name(s)
Artificial Light At Night
Other Intervention Name(s)
ALAN
Intervention Description
90 lux lighting for 19hr/day
Intervention Type
Behavioral
Intervention Name(s)
Sleep Restriction
Intervention Description
5-hr of sleep/night
Primary Outcome Measure Information:
Title
Impairment of Insulin Sensitivity
Description
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (Artificial Light at Night) (LD 19:5) will induce greater impairment of insulin sensitivity (Si), as assessed by an intravenous glucose tolerance test (IVGTT), than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Insulin sensitivity will be assessed via minimal model analysis.
Time Frame
Change between Study Day 7 vs. Study Day 15 and Study Day 24 vs. Study Day 32
Title
Impairment of Glucose Tolerance
Description
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will induce greater impairment of glucose tolerance than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Glucose tolerance will be calculated as the rate of glucose disposal over the first 20 minutes after glucose administration.
Time Frame
Change between Study Day 6 vs. Study Day 14 and Study Day 23 vs. Study Day 31
Title
Duration of Nocturnal Melatonin Secretion
Description
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will reduce the duration of nocturnal melatonin secretion as compared to baseline more than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Duration of nocturnal melatonin secretion will be determined by the duration of time at which melatonin levels are above 25% of their nightly peak levels.
Time Frame
Change between Study Day 15-16 vs. Study Day 32-33
Secondary Outcome Measure Information:
Title
Levels of long-chain highly unsaturated triglycerides
Description
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will lead to a greater reduction in the levels of long-chain highly unsaturated triglycerides than exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). We will use liquid chromatography-mass spectrometry to detect lipids of interest. We will focus on triglycerides associated with diabetes risk (e.g. TG44:1, TG46:1, etc.)
Time Frame
Change between Study Day 7 vs. Study Day 15 and Study Day 24 vs. Study Day 32
Title
Proteomic Profile
Description
Test the hypothesis that exposure to one week of sleep restriction with concurrent exposure to extended duration ALAN (LD 19:5) will lead to a change in the proteomic profile compared with exposure to one week of sleep restriction without extended duration ALAN (LD 14:10). Blood samples will undergo multiplexed proteomic profiling to search for proteins that are reliably increased or decreased following sleep restriction with ALAN compared to sleep restriction without ALAN.
Time Frame
Change between Study Day 7 vs. Study Day 15 and Study Day 24 vs. Study Day 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy adults with conventional and regular sleep-wake timing Non-smokers Completion of medical, psychological, and sleep screening tests Able to spend 33 consecutive days/nights in the laboratory Normal color vision Exclusion Criteria: History of neurological or psychiatric disorder History of sleep disorder or regular use of sleep-promoting medication Current prescription, herbal, or over-the-counter medication use Traveling across 2 or more time zones within past 3 months Donating blood within past 8 weeks Worked night or rotating shift work within past 3 years Hearing impairment, visual impairment History of eye trauma or surgery Drug or alcohol dependency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinator
Phone
617-525-8316
Email
BWHALANstudy@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles A Czeisler, PhD, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charles A Czeisler, PhD, MD
Phone
617-732-4013
Email
cacadmin@partners.org
First Name & Middle Initial & Last Name & Degree
Study Coordinator
Phone
617-525-8838
Email
BWHAlanStudy@partners.org

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction

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