NCT07471126

Brief Summary

Irregular sleep timing and sleep deficiency are pervasive in society despite evidence that sleep deficiency impairs cognition and is linked to neurodegenerative disease. Potential pathways underlying the adverse cognitive function and brain health associated with irregular insufficient sleep include misalignment of sleep from the internal \~24-hour body clock and brain oxidative stress. This research will investigate these putative pathways and inform future interventions to mitigate the impact of sleep loss on cognition and brain health.

Trial Health

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Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
38mo left

Started Mar 2026

Longer than P75 for not_applicable

Status
not yet recruiting

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 Progress5%
Mar 2026Jun 2029

First Submitted

Initial submission to the registry

March 3, 2026

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 13, 2026

Completed
17 days until next milestone

Study Start

First participant enrolled

March 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2029

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 3, 2026

Last Update Submit

March 11, 2026

Conditions

Non-visual Effects of LightChronic Variable Sleep Deficiency

Keywords

SleepCircadianLight exposureOxidative Stress

Outcome Measures

Primary Outcomes (4)

  • circadian phase shifts in melatonin sulfate rhythm

    Baseline: Day 1 of study, Final: Day 8 of study

  • Accuracy on the matrix reasoning task

    Daily over 8 days throughout study intervention

  • WASO on the PSG

    Baseline sleep, first short sleep, second short sleep.

  • MRS-derived GSH in the mPFC

    Baseline: Day 1 of study, Final: Day 8 of study

Study Arms (4)

Dim light control

EXPERIMENTAL
Behavioral: Dim LightBehavioral: Control sleep

Dim-light CVSD

EXPERIMENTAL
Behavioral: Chronic Variable Sleep DeficiencyBehavioral: Dim Light

Room-light CVSD

EXPERIMENTAL
Behavioral: Chronic Variable Sleep DeficiencyBehavioral: Room light

SCIL CVSD

EXPERIMENTAL
Behavioral: Chronic Variable Sleep DeficiencyBehavioral: Sleep- and Circadian-Informed Lighting

Interventions

Sleep- and Circadian-Informed LightingBEHAVIORAL

Ambient visible light exposure with modulated intensity and spectrum

SCIL CVSD
Room lightBEHAVIORAL

\~90 lux ambient lighting while awake

Room-light CVSD
Control sleepBEHAVIORAL

Nightly 8-h sleep opportunity

Dim light control
Chronic Variable Sleep DeficiencyBEHAVIORAL

Repeated cycles of sleep restriction followed by recovery sleep.

Dim-light CVSDRoom-light CVSDSCIL CVSD
Dim LightBEHAVIORAL

\<3 lux dim ambient lighting while awake

Dim light controlDim-light CVSD

Eligibility Criteria

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

You may qualify if:

  • Healthy participants 18-40 years old.

You may not qualify if:

  • Volunteers must be drug-free (including caffeine, nicotine, and alcohol) for the entire duration of the study, with no history of drug or alcohol dependency.
  • Subjects must be free from any significant impairments of the visual system, including color blindness.
  • Subjects must be ambulatory, have no major visual or auditory handicaps, and be free from any major acute, chronic or debilitating medical conditions.
  • history of psychiatric illnesses or psychiatric disorders
  • History of consistent work during the overnight hours for the one year prior to study.
  • History of transmeridian travel \>2 times zones, will require a 1 week wash out per hour of time difference from the Eastern Standard/Daylight Time zone.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Sleep

Intervention Hierarchy (Ancestors)

Nervous System Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Shadab A Rahman, PhD

CONTACT

617-525-8830srahman@bwh.harvard.edu

Leilah K Grant, PhD

CONTACT

617-525-7118lgrant@bwh.harvard.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Investigator

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 13, 2026

Study Start

March 30, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

June 30, 2029

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share