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NCT06009289 Clinical Trial

Light and Sleep Fragmentation

Mild Cognitive Impairment Clinical Trial

Official title:
Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06009289
Other study ID # IRB-71788
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
Start date June 1, 2026
Est. completion date May 30, 2028

Study information
Verified date August 2023
Source VA Palo Alto Health Care System
Contact Renske Lok, PhD
Email rlok@stanford.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date May 30, 2028
Est. primary completion date May 30, 2028
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 99 Years
Eligibility Inclusion Criteria: - Mild Cognitive Impairment - Age >65 Exclusion Criteria: - Severe depression - Unstable psychiatric or medical disease - Acute infection

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Light therapy
One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Locations
Country Name City State
United States Stanford University Redwood City California

Sponsors (2)
Lead Sponsor Collaborator
Stanford University National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sleep fragmentation 24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation 4 weeks
Secondary Cognition Performance on the WAIS-4 6 months
Secondary Mood Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology 6 months
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