LightNCT05317559
Cardiometabolic Outcomes With Light Exposure During Sleep
A study testing room light in people with Light, run by Northwestern University.
Trial summary
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Light
- What is being tested?
- room light
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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.
About this study
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.
Read the 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.
- Conditions
- Light
- Being tested
- room light
- Keywords
- light, sleep, metabolism, sympathetic nervous system, insulin resistance
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
room lightBehavioural
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 group | Role | What they receive |
|---|---|---|
| room light | Experimental | 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). Receives: Behavioral: room light |
| dim light | No intervention | The dim light condition (n=10) included two consecutive nights of sleep in dim light. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matsuda Index
OGTT
Measured: Day 2
Matsuda Index
OGTT
Measured: Day 3
HOMA-IR
Fasting
Measured: Day 2
HOMA-IR
Fasting
Measured: Day 3
Secondary outcomes (10)
Sleep Stages
Stage N1, N2, N3
Measured: Night 1
Sleep Stages
Stage N1, N2, N3
Measured: Night 2
Sleep Stages
Stage N1, N2, N3
Measured: Night 3
Heart Rate
beat to beat
Measured: Night 2
Heart Rate
beat to beat
Measured: Night 3
Blood pressure
diastolic/systolic
Measured: Day 2
Blood pressure
diastolic/systolic
Measured: Day 3
Slow Wave Activity
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
Measured: Night 1
Slow Wave Activity
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
Measured: Night 2
Slow Wave Activity
Spectral power in the Slow Wave Activity (0.5 to 4 Hz)
Measured: Night 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study startFeb 2014
- Primary completionJan 2018
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LightStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phyllis Zee, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05317559
- Sponsor's protocol ID
- STU00094737
- Status last verified
- Mar 2022
- First submitted
- 9 Dec 2021
- Last updated
- 8 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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)
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiometabolic Outcomes With Light Exposure During Sleep
- ClinicalTrials.gov ID
- NCT05317559
- Acronym / sponsor ID
- STU00094737
- Conditions
- Light
- Keywords
- light, sleep, metabolism, sympathetic nervous system, insulin resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| room light | Experimental | Behavioral: room lightThe 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 intervention | –The dim light condition (n=10) included two consecutive nights of sleep in dim light. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| room lightThe 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. | Behavioural | room light |
Primary outcome
Matsuda Index
Time frame: Day 2
OGTT
Matsuda Index
Time frame: Day 3
OGTT
HOMA-IR
Time frame: Day 2
Fasting
HOMA-IR
Time frame: Day 3
Fasting
10 secondary outcomes
Sleep Stages
Time frame: Night 1
Sleep Stages
Time frame: Night 2
Sleep Stages
Time frame: Night 3
Heart Rate
Time frame: Night 2
Heart Rate
Time frame: Night 3
Blood pressure
Time frame: Day 2
Blood pressure
Time frame: Day 3
Slow Wave Activity
Time frame: Night 1
Slow Wave Activity
Time frame: Night 2
Slow Wave Activity
Time frame: Night 3
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2022.
- Individual participant dataSharing planned: Yes. 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)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing room light in people with Light, run by Northwestern University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matsuda Index (time frame: Day 2). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2022.