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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2022
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study tested the hypothesis that acute exposure to light during nighttime sleep adversely affects cardiometabolic function.


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.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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 dim light condition (n=10) included two consecutive nights of sleep in dim light.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Outcome

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
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