- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05317559
Cardiometabolic Outcomes With Light Exposure During Sleep
March 30, 2022 updated by: Phyllis Zee, Northwestern University
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.
Study Overview
Detailed Description
This study tested the hypothesis that acute exposure to light during sleep adversely affects next morning glucose homeostasis and whether this effect occurs via reduced sleep quality, melatonin suppression, or sympathetic nervous system (SNS) activation during sleep.
Twenty young adults participated in this parallel-group study design.
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.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Due to the metabolic stress associated with pregnancy and breastfeeding, patients who were pregnant or breastfeeding were also excluded.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: room light
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 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.
|
|
No Intervention: dim light
The dim light condition (n=10) included two consecutive nights of sleep in dim light.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Matsuda Index
Time Frame: Day 2
|
OGTT
|
Day 2
|
|
Matsuda Index
Time Frame: Day 3
|
OGTT
|
Day 3
|
|
HOMA-IR
Time Frame: Day 2
|
Fasting
|
Day 2
|
|
HOMA-IR
Time Frame: Day 3
|
Fasting
|
Day 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Sleep Stages
Time Frame: Night 1
|
Stage N1, N2, N3
|
Night 1
|
|
Sleep Stages
Time Frame: Night 2
|
Stage N1, N2, N3
|
Night 2
|
|
Sleep Stages
Time Frame: Night 3
|
Stage N1, N2, N3
|
Night 3
|
|
Heart Rate
Time Frame: Night 2
|
beat to beat
|
Night 2
|
|
Heart Rate
Time Frame: Night 3
|
beat to beat
|
Night 3
|
|
Blood pressure
Time Frame: Day 2
|
diastolic/systolic
|
Day 2
|
|
Blood pressure
Time Frame: Day 3
|
diastolic/systolic
|
Day 3
|
|
Slow Wave Activity
Time Frame: Night 1
|
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
|
Night 1
|
|
Slow Wave Activity
Time Frame: Night 2
|
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
|
Night 2
|
|
Slow Wave Activity
Time Frame: Night 3
|
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
|
Night 3
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Melatonin
Time Frame: Day 2
|
pg/ml
|
Day 2
|
|
Melatonin
Time Frame: Day 3
|
pg/ml
|
Day 3
|
|
subjective sleepiness
Time Frame: Day 2
|
sleepiness level
|
Day 2
|
|
subjective sleepiness
Time Frame: Day 3
|
sleepiness level
|
Day 3
|
|
hunger
Time Frame: Day 2
|
hunger level
|
Day 2
|
|
hunger
Time Frame: Day 3
|
hunger level
|
Day 3
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Actual)
January 1, 2018
Study Completion (Actual)
July 1, 2018
Study Registration Dates
First Submitted
December 9, 2021
First Submitted That Met QC Criteria
March 30, 2022
First Posted (Actual)
April 8, 2022
Study Record Updates
Last Update Posted (Actual)
April 8, 2022
Last Update Submitted That Met QC Criteria
March 30, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- STU00094737
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Light
-
University of BaselHorizon 2020 - European CommissionNot yet recruitingLight FlashingSwitzerland
-
Mental Health Services in the Capital Region, DenmarkElforskActive, not recruiting
-
Istanbul University - Cerrahpasa (IUC)Completed
-
Emine YıldırımNot yet recruiting
-
Peking University People's HospitalRecruiting
-
Mohamed samy El-sayedCompletedLight Fluorescence DeviceEgypt
-
LightGuardSuspended
-
Second Affiliated Hospital, School of Medicine,...Not yet recruitingLight Chain Cardiac Amyloidosis
-
Shanghai Chia Tai Tianqing Pharmaceutical Technology...RecruitingSystemic Light Chain AmyloidosisChina
-
Emine YıldırımNot yet recruiting
Clinical Trials on room light
-
University of BergenCompletedDementia | Sleep Fragmentation | Behavioural and Psychiatric Symptoms of DementiaNorway
-
University of Colorado, DenverTerminatedMyocardial Infarction | Coronary ArteriosclerosisUnited States
-
Southeast University, ChinaHohhot First HospitalRecruiting
-
Pınar ErdoğanCompletedLabor Progress | Labor Pain and AnxietyTurkey (Türkiye)
-
Michigan State UniversityMcLaren Health CareRecruitingPregnancy Related | Labor; Poor | Uterine Contractions WeakUnited States
-
University of PittsburghShadyside Hospital FoundationCompleted
-
Brigham and Women's HospitalNot yet recruitingNon-visual Effects of Light | Chronic Variable Sleep Deficiency
-
Centre Hospitalier EsquirolRecruitingPersonality Disorders | Psychotic Disorders | Mood DisordersFrance
-
Amasya UniversityEge UniversityActive, not recruiting
-
Mayo ClinicSteelcaseCompletedInternal Medicine Patients | Participating StaffUnited States