NCT00946530

Brief Summary

The aim of this study is to demonstrate the efficacy of timed exposure to bright light for the treatment of disturbed nighttime sleep and daytime wake in community-dwelling dementia patients and their caregivers, and to determine if there are genetic relationships between memory problems and sleep problems

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
4.9 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

March 29, 2017

Completed
Last Updated

October 3, 2018

Status Verified

October 1, 2018

Enrollment Period

6.3 years

First QC Date

July 23, 2009

Results QC Date

December 5, 2013

Last Update Submit

October 1, 2018

Conditions

Sleep Initiation and Maintenance Disorders

Outcome Measures

Primary Outcomes (1)

  • Total Sleep Time

    The amount of actual sleep time in a sleep episode.

    2 weeks

Secondary Outcomes (1)

  • WASO (Wake After Sleep Onset)

    2 weeks

Study Arms (2)

Bright Light

EXPERIMENTAL

received bright light

Device: Bright light

Control

PLACEBO COMPARATOR

received regular light

Device: Control

Interventions

Bright lightDEVICE

Participants uses bright light

Bright Light
ControlDEVICE

Participants uses dim light

Control

Eligibility Criteria

Age55 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Stanford Alzheimer's Disease Core Center member or potential member, with diagnostic criteria met for probable AD, living with caregiver willing to participate in the protocol
  • Non-institutionalized
  • Caregivers:

You may not qualify if:

  • History of manic or bipolar disorder
  • Prior bright light treatment
  • Irregular or non-24 hour sleep/wake cycle
  • Positive result on multi-staged RLS/PLMD
  • RDI \>20 on overnight EdenTrace® recording
  • Caregivers:
  • History of manic or bipolar disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (2)

  • Spira AP, Friedman L, Beaudreau SA, Ancoli-Israel S, Hernandez B, Sheikh J, Yesavage J. Sleep and physical functioning in family caregivers of older adults with memory impairment. Int Psychogeriatr. 2010 Mar;22(2):306-11. doi: 10.1017/S1041610209991153. Epub 2009 Nov 30.

    PMID: 19943990RESULT

  • Friedman L, Spira AP, Hernandez B, Mather C, Sheikh J, Ancoli-Israel S, Yesavage JA, Zeitzer JM. Brief morning light treatment for sleep/wake disturbances in older memory-impaired individuals and their caregivers. Sleep Med. 2012 May;13(5):546-9. doi: 10.1016/j.sleep.2011.11.013. Epub 2012 Mar 10.

    PMID: 22406033RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Results Point of Contact

Title
Jerome A. Yesavage, MD
Organization
Stanford University
yesavage@stanford.edu
650-493-5000

Study Officials

  • Jerome A Yesavage

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry

Study Record Dates

First Submitted

July 23, 2009

First Posted

July 27, 2009

Study Start

September 1, 2004

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

October 3, 2018

Results First Posted

March 29, 2017

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

This was not required at the time.

Locations

US(1)