Cardiometabolic Outcomes With Light Exposure During Sleep
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.
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 Feb 2014
Longer than P75 for not_applicable
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
Study Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedFirst Submitted
Initial submission to the registry
December 9, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2022
CompletedApril 8, 2022
March 1, 2022
3.9 years
December 9, 2021
March 30, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Matsuda Index
OGTT
Day 2
Matsuda Index
OGTT
Day 3
HOMA-IR
Fasting
Day 2
HOMA-IR
Fasting
Day 3
Secondary Outcomes (10)
Sleep Stages
Night 1
Sleep Stages
Night 2
Sleep Stages
Night 3
Heart Rate
Night 2
Heart Rate
Night 3
- +5 more secondary outcomes
Other Outcomes (6)
Melatonin
Day 2
Melatonin
Day 3
subjective sleepiness
Day 2
- +3 more other outcomes
Study Arms (2)
room light
EXPERIMENTALThe room light condition (n=10) included one night of sleep in dim light (\< 3 lux) followed by one night of sleep with overhead room lighting (100 lux).
dim light
NO INTERVENTIONThe dim light condition (n=10) included two consecutive nights of sleep in dim light.
Interventions
The room light condition (n=10) included one night of sleep in dim light (\< 3 lux) followed by one night of sleep with overhead room lighting (100 lux). The dim light condition (n=10) included two consecutive nights of sleep in dim light.
Eligibility Criteria
You may qualify if:
- healthy adults
- ages 18-40 years
- habitual sleep duration of 6.5-8.5 hours
- habitual sleep onset of 9:00 pm-1:00 am
You may not qualify if:
- any sleep disorder as assessed by history and screening questionnaires for obstructive sleep apnea (Berlin) and excessive daytime sleepiness (ESS \>12), and by PSG to exclude sleep apnea (apnea hypopnea index ≥ 15), periodic leg movements (movement arousal index ≥ 15), or REM sleep behavior disorder;
- history of a cognitive or neurological disorder;
- history of a major psychiatric disorder, including but not limited to mood/anxiety, eating, and alcohol/substance abuse disorders;
- depressed mood (Beck Depression Inventory II score ≥ 20);
- diabetes or other endocrine disorders;
- any gastrointestinal disease requiring dietary adjustment;
- blindness or significant vision loss;
- any unstable or serious medical conditions;
- current or recent (within the past month) of psychoactive, hypnotic, stimulant or analgesic medications;
- shift work or other types of self-imposed irregular sleep schedules;
- obesity (body mass index \> 30 kg/m2);
- history of habitual smoking (6 or more cigarettes per week) or drinking (7 or more alcoholic beverages per week) or caffeine consumption greater than 300 mg per day;
- current use of light therapy;
- use of any other legal or illicit substance that may affect sleep and/or appetite;
- allergy to heparin.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
December 9, 2021
First Posted
April 8, 2022
Study Start
February 1, 2014
Primary Completion
January 1, 2018
Study Completion
July 1, 2018
Last Updated
April 8, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will share
De-identified data to support the findings of the study are available in Arch, the open access Northwestern University Institutional Repository (https://doi.org/10.21985/n2-9zrx-ev05)