Light Clinical Trial
Official title:
Cardiometabolic Outcomes With Light Exposure During Sleep
NCT number | NCT05317559 |
Other study ID # | STU00094737 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2014 |
Est. completion date | July 2018 |
Verified date | March 2022 |
Source | Northwestern University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.
Status | Completed |
Enrollment | 20 |
Est. completion date | July 2018 |
Est. primary completion date | January 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 40 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Northwestern University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Melatonin | pg/ml | Day 2 | |
Other | Melatonin | pg/ml | Day 3 | |
Other | subjective sleepiness | sleepiness level | Day 2 | |
Other | subjective sleepiness | sleepiness level | Day 3 | |
Other | hunger | hunger level | Day 2 | |
Other | hunger | hunger level | Day 3 | |
Primary | Matsuda Index | OGTT | Day 2 | |
Primary | Matsuda Index | OGTT | Day 3 | |
Primary | HOMA-IR | Fasting | Day 2 | |
Primary | HOMA-IR | Fasting | Day 3 | |
Secondary | Sleep Stages | Stage N1, N2, N3 | Night 1 | |
Secondary | Sleep Stages | Stage N1, N2, N3 | Night 2 | |
Secondary | Sleep Stages | Stage N1, N2, N3 | Night 3 | |
Secondary | Heart Rate | beat to beat | Night 2 | |
Secondary | Heart Rate | beat to beat | Night 3 | |
Secondary | Blood pressure | diastolic/systolic | Day 2 | |
Secondary | Blood pressure | diastolic/systolic | Day 3 | |
Secondary | Slow Wave Activity | Spectral power in the Slow Wave Activity (0.5 to 4 Hz) | Night 1 | |
Secondary | Slow Wave Activity | Spectral power in the Slow Wave Activity (0.5 to 4 Hz) | Night 2 | |
Secondary | Slow Wave Activity | Spectral power in the Slow Wave Activity (0.5 to 4 Hz) | Night 3 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Suspended |
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