NCT04868539

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

Completed NA Results posted Last updated 14 October 2025

What this trial tests

NA trial testing Sleep Restriction with ALAN first, then Sleep Restriction without ALAN in Glucose Intolerance in 14 participants. Completed in 30 May 2024.

Timeline

15 March 2022

Primary endpoint
20 February 2024

30 May 2024

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	basic science
Enrollment	14
Start date	15 March 2022
Primary completion	20 February 2024
Estimated completion	30 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Sleep Restriction with ALAN first, then Sleep Restriction without ALAN
• Sleep Restriction without ALAN first, then sleep restriction with ALAN

Conditions studied

• Glucose Intolerance — all drugs for Glucose Intolerance →
• Sleep Deprivation — all drugs for Sleep Deprivation →
• Sleep — all drugs for Sleep →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 20 to 40, any sex, with Glucose Intolerance or Sleep Deprivation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Impairment of Insulin Sensitivity Primary · Change between Study Day 7 vs. Study Day 15 and Study Day 24 vs. Study Day 32

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.

Group	Value	95% CI
ALAN	-0.80	± 1.63
Without ALAN	0.55	± 4.18

Impairment of Glucose Tolerance Primary · Change between Study Day 6 vs. Study Day 14 and Study Day 23 vs. Study Day 31

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

Group	Value	95% CI
ALAN	524.4	± 376.7
Without ALAN	179.1	± 1121.6

Duration of Nocturnal Melatonin Secretion Primary · Change between Study Day 14-15 (overnight) vs. Study Day 31-32 (overnight)

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.

Group	Value	95% CI
ALAN	432.9	± 90.3
Without ALAN	579.6	± 44.8

Acute Insulin Response to Glucose Secondary · Change from study day 7 to 15 compared to change from study day 24 to 32

Acute Insulin Response as calculated with minimal model analysis, a mathematical model developed by Bergman and colleagues, and represents early insulin release in the body to manage blood glucose levels. Higher values represent a better response and lower values represent a worse response. The mean change in AIRg between exposure and baseline is reported for each arm.

Group	Value	95% CI
ALAN	-110.41	± 472.51
Without ALAN	-37.04	± 203.45

Glucose Effectiveness Secondary · Change from study day 7 to 15 vs change from study day 24 to 32

Glucose Effectiveness as calculated using minimal model analysis, a mathematical model developed by Bergman and colleagues. It represents how well the body can normalize blood glucose independent of insulin. Higher glucose effectiveness (Sg) is generally associated with better metabolic health outcomes.

Group	Value	95% CI
ALAN	-0.00049	± 0.0051
Without ALAN	-0.0012	± 0.0073

Insulin Area-under-the-curve Secondary · Change between Study Day 6 vs. Study Day 14 and Study Day 23 vs. Study Day 31

Insulin area under the curve (AUC) as calculated with trapezoidal method between 0-120min following mixed meal tolerance test.

Group	Value	95% CI
ALAN	663.4	± 917.7
Without ALAN	-71.6	± 702.5

Duration of Endogenous Melatonin Secretory Profile Secondary · Study Day 15-16 vs Study Day 32-33

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 the endogenous melatonin secretory profile 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.

Group	Value	95% CI
ALAN	581.7	± 51.1
Without ALAN	609.6	± 66.1

Adverse events — posted to ClinicalTrials.gov

Time frame: From admission to inpatient study until the participant's last inpatient day (up to 33 days). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Sleep Restriction With ALAN

Serious: 0/12 (0%)

Deaths: 0/12

Sleep Restriction Without ALAN

Serious: 0/12 (0%)

Deaths: 0/12

Other adverse events (6 terms — click to expand)

Reaction	System	Sleep Restriction With ALAN	Sleep Restriction Without …
Lightheadedness	General disorders	—	—
Headache	General disorders	—	—
Nausea	General disorders	—	—
Bruising/petechiae on arm	General disorders	—	—
Chest pressure	General disorders	—	—
Stomach pain	General disorders	—	—

Data from ClinicalTrials.gov NCT04868539 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Melatonin: Facts, Extrapolations and Clinical Trials.
   Boutin JA, Kennaway DJ, Jockers R. · · 2023 · cited 55× · PMID 37371523 · DOI 10.3390/biom13060943