NCT04868539

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 3, 2021

Completed
11 months until next milestone

Study Start

First participant enrolled

March 15, 2022

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 14, 2025

Completed
Last Updated

October 14, 2025

Status Verified

September 1, 2025

Enrollment Period

1.9 years

First QC Date

April 20, 2021

Results QC Date

July 24, 2025

Last Update Submit

September 23, 2025

Conditions

Keywords

Chronic Sleep RestrictionArtificial Light At NightGlucose IntoleranceMelatoninSleep

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

EXPERIMENTAL

Participants 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).

Other: Sleep Restriction with ALAN first, then Sleep Restriction without ALAN

Sleep Restriction without ALAN, then Sleep Restriction with ALAN

EXPERIMENTAL

Participants 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).

Other: Sleep Restriction without ALAN first, then sleep restriction with ALAN

Interventions

Sleep restriction with 90 lux lighting for 19hr/day first, followed by Sleep restriction with 90 lux lighting for 14hr/day

Also known as: ALAN first
Sleep Restriction with ALAN, then Sleep Restriction without ALAN

Sleep restriction with 90 lux lighting for 14hr/day first, followed by Sleep restriction with 90 lux lighting for 19hr/day

Also known as: ALAN second
Sleep Restriction without ALAN, then Sleep Restriction with ALAN

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Location

MeSH Terms

Conditions

Glucose IntoleranceSleep Deprivation

Condition Hierarchy (Ancestors)

HyperglycemiaGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesDyssomniasSleep Wake DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

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

  • Charles A Czeisler, PhD, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

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
Model Details: 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.
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

Locations