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Completed

NCT Number: NCT05317559

Cardiometabolic Outcomes With Light Exposure During Sleep

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Room light

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.

Primary outcomes

  1. Matsuda Index

    Time frame: Day 2

    OGTT

  2. Matsuda Index

    Time frame: Day 3

    OGTT

  3. HOMA-IR

    Time frame: Day 2

    Fasting

  4. HOMA-IR

    Time frame: Day 3

    Fasting

Secondary outcomes

  1. Sleep Stages

    Time frame: Night 1

    Stage N1, N2, N3

  2. Sleep Stages

    Time frame: Night 2

    Stage N1, N2, N3

  3. Sleep Stages

    Time frame: Night 3

    Stage N1, N2, N3

  4. Heart Rate

    Time frame: Night 2

    beat to beat

  5. Heart Rate

    Time frame: Night 3

    beat to beat

  6. Blood pressure

    Time frame: Day 2

    diastolic/systolic

  7. Blood pressure

    Time frame: Day 3

    diastolic/systolic

  8. Slow Wave Activity

    Time frame: Night 1

    Spectral power in the Slow Wave Activity (0.5 to 4 Hz)

  9. Slow Wave Activity

    Time frame: Night 2

    Spectral power in the Slow Wave Activity (0.5 to 4 Hz)

  10. Slow Wave Activity

    Time frame: Night 3

    Spectral power in the Slow Wave Activity (0.5 to 4 Hz)

Other outcomes

  1. Melatonin

    Time frame: Day 2

    pg/ml

  2. Melatonin

    Time frame: Day 3

    pg/ml

  3. subjective sleepiness

    Time frame: Day 2

    sleepiness level

  4. subjective sleepiness

    Time frame: Day 3

    sleepiness level

  5. hunger

    Time frame: Day 2

    hunger level

  6. hunger

    Time frame: Day 3

    hunger level

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 8, 2022
Registry last updated
Apr 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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