Light and Sleep Fragmentation

Sponsor

Stanford University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06009289

Collaborator

National Institute on Aging (NIA) (NIH)

120

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sleep Mild Cognitive Impairment Mood Disorders	Behavioral: Light therapy	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2026

Anticipated Primary Completion Date :

May 30, 2028

Anticipated Study Completion Date :

May 30, 2028

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of care One hour of daily bright light exposure beginning one hour after wake time.	Behavioral: Light therapy One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor
Experimental: Stepped care One hour of daily bright light exposure in the afternoon	Behavioral: Light therapy One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor

Arm

Intervention/Treatment

Active Comparator: Standard of care

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

Behavioral: Light therapy

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

Experimental: Stepped care

One hour of daily bright light exposure in the afternoon

Behavioral: Light therapy

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

Outcome Measures

Primary Outcome Measures

Sleep fragmentation [4 weeks]
24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation

Secondary Outcome Measures

Cognition [6 months]
Performance on the WAIS-4
Mood [6 months]
Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Mild Cognitive Impairment
Age >65

Exclusion Criteria:

Severe depression
Unstable psychiatric or medical disease
Acute infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Redwood City	California	United States	94063

Sponsors and Collaborators

Stanford University
National Institute on Aging (NIA)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jamie M. Zeitzer, Ph.D., Professor, Stanford University

ClinicalTrials.gov Identifier:

NCT06009289

Other Study ID Numbers:

IRB-71788

First Posted:

Aug 24, 2023

Last Update Posted:

Aug 25, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Cognitive Dysfunction

Mood Disorders

Study Results

No Results Posted as of Aug 25, 2023