Influence of Nocturnal Light Exposure on the Impairment of Glucose Tolerance Induced by Chronic Sleep Restriction
1 other identifier
interventional
14
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 20, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
March 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedResults Posted
Study results publicly available
October 14, 2025
CompletedOctober 14, 2025
September 1, 2025
1.9 years
April 20, 2021
July 24, 2025
September 23, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Impairment of Insulin Sensitivity
Insulin sensitivity (Si) is assessed via minimal model analysis, a mathematical model developed by Bergman and colleagues. Higher values represent better insulin sensitivity and lower values represent impaired insulin sensitivity. The mean change in Si between exposure and baseline is reported for each arm.
Change between Study Day 7 vs. Study Day 15 and Study Day 24 vs. Study Day 32
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 area under the curve from minutes 0-120 following a mixed meal tolerance test
Change between Study Day 6 vs. Study Day 14 and Study Day 23 vs. Study Day 31
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 acutely 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 a threshold calculated as 25% of peak-to-trough amplitude at baseline in dim light.
Change between Study Day 14-15 (overnight) vs. Study Day 31-32 (overnight)
Secondary Outcomes (4)
Acute Insulin Response to Glucose
Change from study day 7 to 15 compared to change from study day 24 to 32
Glucose Effectiveness
Change from study day 7 to 15 vs change from study day 24 to 32
Insulin Area-under-the-curve
Change between Study Day 6 vs. Study Day 14 and Study Day 23 vs. Study Day 31
Duration of Endogenous Melatonin Secretory Profile
Study Day 15-16 vs Study Day 32-33
Study Arms (2)
Sleep Restriction with ALAN, then Sleep Restriction without ALAN
EXPERIMENTALParticipants first received Sleep Restriction with extended duration Artificial Light At Night (ALAN), during which sleep episodes were shortened to 5 hours and participants remained in room lighting for the full wake episode (19h room light, 5h darkness). After a washout of 10 days, participants received Sleep Restriction without ALAN, during which sleep episodes were shortened to 5 hours but participants were kept in dim light for the extra time awake (14h room light, 5h dim light, 5h darkness).
Sleep Restriction without ALAN, then Sleep Restriction with ALAN
EXPERIMENTALParticipants first received Sleep Restriction without extended duration Artificial Light At Night (ALAN), during which sleep episodes were shortened to 5 hours but participants were kept in dim light for the extra time awake (14h room light, 5h dim light, 5h darkness). After a washout of 10 days, participants received Sleep Restriction with extended duration ALAN, during which sleep episodes were shortened to 5 hours and participants remained in room lighting for the full wake episode (19h room light, 5h darkness).
Interventions
Sleep restriction with 90 lux lighting for 19hr/day first, followed by Sleep restriction with 90 lux lighting for 14hr/day
Sleep restriction with 90 lux lighting for 14hr/day first, followed by Sleep restriction with 90 lux lighting for 19hr/day
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study enrollment was ended early due to budgetary reasons, so we were unable to study the total number of participants planned. Thus, we may have limited statistical power to interpret the results.
Results Point of Contact
- Title
- Dr. Charles Czeisler, Ph.D., M.D.
- Organization
- Brigham and Women's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Charles A Czeisler, PhD, MD
Brigham and Women's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- The order in which subjects undergo the two sleep interventions will be randomized.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 20, 2021
First Posted
May 3, 2021
Study Start
March 15, 2022
Primary Completion
February 20, 2024
Study Completion
May 30, 2024
Last Updated
October 14, 2025
Results First Posted
October 14, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share