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
• Status: Not yet recruiting
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Mood Disorders
• Sleep

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