NCT05317559

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2014

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
Last Updated

April 8, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

December 9, 2021

Last Update Submit

March 30, 2022

Conditions

Keywords

lightsleepmetabolismsympathetic nervous systeminsulin resistance

Outcome Measures

Primary Outcomes (4)

  • Matsuda Index

    OGTT

    Day 2

  • Matsuda Index

    OGTT

    Day 3

  • HOMA-IR

    Fasting

    Day 2

  • HOMA-IR

    Fasting

    Day 3

Secondary Outcomes (10)

  • Sleep Stages

    Night 1

  • Sleep Stages

    Night 2

  • Sleep Stages

    Night 3

  • Heart Rate

    Night 2

  • Heart Rate

    Night 3

  • +5 more secondary outcomes

Other Outcomes (6)

  • Melatonin

    Day 2

  • Melatonin

    Day 3

  • subjective sleepiness

    Day 2

  • +3 more other outcomes

Study Arms (2)

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).

Behavioral: room light

dim light

NO INTERVENTION

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

Interventions

room lightBEHAVIORAL

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.

room light

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 9, 2021

First Posted

April 8, 2022

Study Start

February 1, 2014

Primary Completion

January 1, 2018

Study Completion

July 1, 2018

Last Updated

April 8, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

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)