Cardiometabolic Outcomes With Light Exposure During Sleep

NCT ID: NCT05317559

Last Updated: 2022-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Light

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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).

Group Type EXPERIMENTAL

room light

Intervention Type BEHAVIORAL

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.

dim light

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Phyllis Zee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STU00094737

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Aging Program Project Grant 6
NCT03490825 COMPLETED NA
Light Timing Study
NCT04753190 RECRUITING NA