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

Status

Completed

Conditions

Intervention / Treatment

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.

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

Clinical Trials on room light

Subscribe