NCT05015478

Brief Summary

The investigator will investigate how light delivering 40 hertz (Hz) affects subjective sleep and cognition in a controlled laboratory study. A lab study will allow the collection of electroencephalogram (EEG) data, perform cognitive tests, and observe the response in those with mild cognitive impairment (MCI) compared to a healthy control group (HC). Participants will attend two study sessions over the course of two weeks. During both sessions, all participants will experience 10 minutes of a low-level light, followed by a data collection period which involves a sleepiness rating, an electroencephalogram (EEG) recording, and a computerized memory test. Participants will then experience either a RL or a placebo RL condition for one hour, after which there will be a second data collection.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

January 10, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2023

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

December 3, 2024

Completed
Last Updated

December 3, 2024

Status Verified

November 1, 2024

Enrollment Period

1.5 years

First QC Date

August 12, 2021

Results QC Date

August 22, 2024

Last Update Submit

November 13, 2024

Conditions

Mild Cognitive Impairment

Keywords

Light TreatmentCircadian RhythmsGamma Wave EntrainmentRhythmic LightMild Alzheimer's DiseaseSleepMemoryElectroencephalogram

Outcome Measures

Primary Outcomes (1)

  • Change in Electroencephalography (EEG) Power at 40 Hertz (Hz)

    Electroencephalography (EEG) recordings - the change in 40 Hz gamma power, computed by calculating the difference between the average gamma power at baseline (T1) and during the light intervention (T2). This difference was obtained by subtracting baseline 40 Hz power from the intervention 40 Hz power to assess acute neural effects

    baseline and during the light intervention

Secondary Outcomes (2)

  • Mean Change in Subjective Sleepiness Using the Karolinska Sleepiness Scale (KSS)

    Baseline and 1 hour after intervention (intervention is 2 hours)

  • Cognition Using a Working Memory Task

    1 hour after intervention (intervention is 2 hours)

Study Arms (2)

Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting

ACTIVE COMPARATOR

1. hour intervention period where active lighting is experienced by participants. then 1 hour intervention period where an inactive, placebo lighting condition is experienced by participants. 2. sessions, 1 week apart

Device: Tailored Rhythmic Lighting Intervention

Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting

PLACEBO COMPARATOR

1. hour intervention period where an inactive, placebo lighting condition is experienced by participants. then 1 hour intervention period where active lighting is experienced by participants. 2. sessions, 1 week apart

Device: Placebo Rhythmic Lighting Intervention

Interventions

Tailored Rhythmic Lighting InterventionDEVICE

40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.

Active Tailored Rhythmic Lighting then Inactive Placebo Rhythmic Lighting
Placebo Rhythmic Lighting InterventionDEVICE

Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered at randomly varying frequencies of 20 Hz and 50 Hz, specifically avoiding the frequency of 40 Hz. The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.

Inactive Placebo Rhythmic Lighting then Active Tailored Rhythmic Lighting

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must be diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment (MoCA) score between 17 and 25
  • For the age-matched healthy controls, participants must not be diagnosed with mild cognitive impairment or Alzheimer's disease related dementias (MoCA score above 25).
  • Participants must score a 5 or less in the Pittsburgh Sleep Quality Index (PSQI)

You may not qualify if:

  • All participants must not be taking sleeping medication or oral melatonin
  • Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
  • residence in a skilled nursing facility or long-term care
  • Major organ failure (e.g., kidney failure)
  • Uncontrolled generalized disorders such as hypertension or diabetes
  • Obstructing cataracts, macular degeneration, and blindness
  • Severe sleep apnea or restless leg syndrome
  • History of epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Light and Health Research Center

Menands, New York, 12204, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (3)

  • Akerstedt T, Gillberg M. Subjective and objective sleepiness in the active individual. Int J Neurosci. 1990 May;52(1-2):29-37. doi: 10.3109/00207459008994241.

    PMID: 2265922BACKGROUND

  • Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.

    PMID: 15817019BACKGROUND

  • Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.

    PMID: 1947597BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Mariana Figueiro PhD
Organization
Icahn School Of Medicine at Mount Sinai
Mariana.Figueiro@mountsinai.org
212-241-6500

Study Officials

  • Mariana Figueiro, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Population Health Science and Policy

Study Record Dates

First Submitted

August 12, 2021

First Posted

August 20, 2021

Study Start

January 10, 2022

Primary Completion

July 12, 2023

Study Completion

July 12, 2023

Last Updated

December 3, 2024

Results First Posted

December 3, 2024

Record last verified: 2024-11

Locations

US(2)