NCT06009289

Brief Summary

This trial will examine scheduled exposure to bright light in the morning and afternoon as a countermeasure to sleep fragmentation in older individuals with mild cognitive impairment.

Trial Health

63
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Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for phase_4

Timeline
24mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

August 18, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 24, 2023

Completed
2.8 years until next milestone

Study Start

First participant enrolled

June 1, 2026

Expected
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2028

Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

August 18, 2023

Last Update Submit

August 23, 2023

Conditions

SleepMild Cognitive ImpairmentMood Disorders

Outcome Measures

Primary Outcomes (1)

  • Sleep fragmentation

    24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation

    4 weeks

Secondary Outcomes (2)

  • Cognition

    6 months

  • Mood

    6 months

Study Arms (2)

Standard of care

ACTIVE COMPARATOR

One hour of daily bright light exposure beginning one hour after wake time.

Behavioral: Light therapy

Stepped care

EXPERIMENTAL

One hour of daily bright light exposure in the afternoon

Behavioral: Light therapy

Interventions

Light therapyBEHAVIORAL

One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Standard of careStepped care

Eligibility Criteria

Age65 Years - 99 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Mild Cognitive Impairment
  • Age \>65

You may not qualify if:

  • Severe depression
  • Unstable psychiatric or medical disease
  • Acute infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Cognitive DysfunctionMood Disorders

Interventions

Phototherapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Renske Lok, PhD

CONTACT

rlok@stanford.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 18, 2023

First Posted

August 24, 2023

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

May 30, 2028

Study Completion (Estimated)

May 30, 2028

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will share

After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
within six months after publication; no restrictions on duration of availability
More information

Locations

US(1)