Light and Sleep Fragmentation

Phase 4

Not yet recruiting

• Conditions: Mild Cognitive Impairment; Mood Disorders; Sleep
• Interventions: Behavioral: Light therapy

• Registration Number: NCT06009289
• Lead Sponsor: Stanford University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-08
• Study First Submitted: 2023-08-18
• Study First Submitted QC: 2023-08-18
• Last Update Submitted: 2023-08-23
• Study First Posted: 2023-08-24
• Last Update Posted: 2023-08-25
• Study Start: 2026-06-01
• Primary Completion: 2028-05-30
• Study Completion: 2028-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Mild Cognitive Impairment
• Age >65

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Standard of care	Light therapy	One hour of daily bright light exposure beginning one hour after wake time.
Stepped care	Light therapy	One hour of daily bright light exposure in the afternoon

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Redwood City, California, United States