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Light and Sleep Fragmentation

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

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06009289
Enrollment
120
Registered
2023-08-24
Start date
2026-06-01
Completion date
2028-05-30
Last updated
2023-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Mood Disorders, Sleep

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.

Interventions

BEHAVIORALLight therapy

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

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to 99 Years
Healthy volunteers
Yes

Inclusion criteria

* Mild Cognitive Impairment * Age \>65

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Sleep fragmentation4 weeks24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation

Secondary

MeasureTime frameDescription
Cognition6 monthsPerformance on the WAIS-4
Mood6 monthsGeriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology

Countries

United States

Contacts

Primary ContactRenske Lok, PhD
rlok@stanford.edu

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026