Back to resultsLight and Sleep Fragmentation
Primary Purpose
Sleep, Mild Cognitive Impairment, Mood Disorders
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Light therapy
Sponsored by
About this trial
This is an interventional treatment trial for Sleep
Eligibility Criteria
Inclusion Criteria: Mild Cognitive Impairment Age >65 Exclusion Criteria: Severe depression Unstable psychiatric or medical disease Acute infection
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard of care
Stepped care
Arm Description
One hour of daily bright light exposure beginning one hour after wake time.
One hour of daily bright light exposure in the afternoon
Outcomes
Primary Outcome Measures
Sleep fragmentation
24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation
Secondary Outcome Measures
Cognition
Performance on the WAIS-4
Mood
Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology
Full Information
NCT ID
NCT06009289
First Posted
August 18, 2023
Last Updated
August 23, 2023
Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT06009289
Brief Title
Light and Sleep Fragmentation
Official Title
Application of Precision Medicine to Phototherapy: a Stepped Care Approach to Consolidate Sleep and Slow Cognitive Decline in Older Adults
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2026 (Anticipated)
Primary Completion Date
May 30, 2028 (Anticipated)
Study Completion Date
May 30, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep, Mild Cognitive Impairment, Mood Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Sequential Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
One hour of daily bright light exposure beginning one hour after wake time.
Arm Title
Stepped care
Arm Type
Experimental
Arm Description
One hour of daily bright light exposure in the afternoon
Intervention Type
Behavioral
Intervention Name(s)
Light therapy
Intervention Description
One hour of exposure to bright light, either by being outdoors or with a phototherapy lamp if indoor
Primary Outcome Measure Information:
Title
Sleep fragmentation
Description
24 hour sleep wake patterns will be quantitated with a non-parametric measure, intradaily variation
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Cognition
Description
Performance on the WAIS-4
Time Frame
6 months
Title
Mood
Description
Geriatric Depression Scale, range: 0-15 with higher scores being associated with greater depressive symptomatology
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Mild Cognitive Impairment
Age >65
Exclusion Criteria:
Severe depression
Unstable psychiatric or medical disease
Acute infection
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Renske Lok, PhD
Email
rlok@stanford.edu
Facility Information:
Facility Name
Stanford University
City
Redwood City
State/Province
California
ZIP/Postal Code
94063
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renske Lok, PhD
Email
rlok@stanford.edu
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After completion of study and publication of data, deidentified IPD will be uploaded to Dryad with documentation. Analytic code will be shared with Github
IPD Sharing Time Frame
within six months after publication; no restrictions on duration of availability
IPD Sharing URL
https://laneguides.stanford.edu/DataManagement/Sharing
Learn more about this trial
Light and Sleep Fragmentation
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