Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00946530
• Collaborator: Palo Alto Veterans Institute for Research (Other)
• Enrollment: 118
• Location: 1
• Arms: 2
• Duration (Months): 75
• Patients Per Site Per Month: 1.6

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Sleep Initiation and Maintenance Disorders	Device: Bright light; Device: Control	N/A

Detailed Description

1. Efficacy: Up to 4 weeks of morning bright light exposure will be more efficacious than morning dim light in consolidating nighttime sleep as assessed by actigraphy.

2. Predictors of response: We expect the primary predictor of treatment response will be initial MMSE score. Secondary predictors include baseline sleep/wake and circadian parameters and age.

3. Effectiveness: Bright light treatment will be more effective than dim light in improving quality of life.

4. An understanding of some of the genetic markers of memory and/or sleep problems.

Study Design

• Study Type: Interventional
• Actual Enrollment: 118 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Light Treatment for Sleep/Wake Disturbances in Alzheimer's Disease
• Study Start Date: Sep 1, 2004
• Actual Primary Completion Date: Dec 1, 2010
• Actual Study Completion Date: Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bright Light received bright light	Device: Bright light; Participants uses bright light
Placebo Comparator: Control received regular light	Device: Control; Participants uses dim light

Outcome Measures

Primary Outcome Measures

1. Total Sleep Time [2 weeks]

   The amount of actual sleep time in a sleep episode.

Secondary Outcome Measures

1. WASO (Wake After Sleep Onset) [2 weeks]

   WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 55 Years to 100 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:Alzheimer's Disease Patients:

• 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:

• Living in home of AD patient and willing to participate in protocol Exclusion

Criteria:Alzheimer's Disease Patients:

• 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

• Medical/Ophthalmologic Exclusions

• RDI >20 on overnight EdenTrace® recording

Caregivers:

• History of manic or bipolar disorder

• Medical/Ophthalmologic Exclusions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	VA Palo Alto Health Care System	Palo Alto	California	United States	94304

Sponsors and Collaborators

• Stanford University
• Palo Alto Veterans Institute for Research

Investigators

• Principal Investigator: Jerome A Yesavage, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jerome A Yesavage,, Professor of Psychiatry, Stanford University
• ClinicalTrials.gov Identifier: NCT00946530
• Other Study ID Numbers: SU-06302009-2840; 1677
• First Posted: Jul 27, 2009
• Last Update Posted: Oct 3, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Additional relevant MeSH terms: Alzheimer Disease; Sleep Initiation and Maintenance Disorders

Study Results

Participant Flow

Recruitment Details	Participants were recruited from the local community, from 2004-2008
Pre-assignment Detail	diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.

Arm/Group Title	Bright Light - AD Patient	Dim Light (Control) - AD Patients	Bright Light - Caregiver	Dim Light (Control) - Caregiver
Arm/Group Description	AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks	AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks	Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks	Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
Period Title: Overall Study
STARTED	32	27	32	27
COMPLETED	31	23	31	23
NOT COMPLETED	1	4	1	4

Baseline Characteristics

Arm/Group Title	Bright Light-AD Patients	Dim Light (Control) - AD Patients	Bright Light - Caregivers	Dim Light (Control) - Caregivers	Total
Arm/Group Description	AD patients received bright light	AD patients received dim light in the Control condition	Caregivers received bright light	Caregivers received dim light in the Control condition	Total of all reporting groups
Overall Participants	31	23	31	23	108
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%	0 0%
>=65 years	31 100%	23 100%	31 100%	23 100%	108 100%
Sex: Female, Male (Count of Participants)
Female	12 38.7%	11 47.8%	22 71%	14 60.9%	59 54.6%
Male	19 61.3%	12 52.2%	9 29%	9 39.1%	49 45.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	3 9.7%	0 0%	5 16.1%	0 0%	8 7.4%
Not Hispanic or Latino	28 90.3%	23 100%	26 83.9%	23 100%	100 92.6%
Unknown or Not Reported	0 0%	0 0%	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%	0 0%	0 0%
Asian	1 3.2%	1 4.3%	1 3.2%	1 4.3%	4 3.7%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%	0 0%	0 0%
White	29 93.5%	22 95.7%	29 93.5%	22 95.7%	102 94.4%
More than one race	0 0%	0 0%	0 0%	0 0%	0 0%
Unknown or Not Reported	1 3.2%	0 0%	1 3.2%	0 0%	2 1.9%
Region of Enrollment (participants) [Number]
United States	31 100%	23 100%	31 100%	23 100%	108 100%

Outcome Measures

1. Primary Outcome

Title	Total Sleep Time
Description	The amount of actual sleep time in a sleep episode.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

dyads consisting of 1 AD patient and 1 caregiver

Arm/Group Title	Bright Light - AD Patient	Dim Light (Control) - AD Patients	Bright Light - Caregiver	Dim Light (Control) - Caregiver
Arm/Group Description	AD patient received bright light	AD patient received regular (dim) light	Caregiver received Bright Light	Caregiver received regular (dim) Light
Measure Participants	31	23	31	23
Mean (Standard Deviation) [units on a scale (minutes)]	393 (127)	420 (125)	398 (65.4)	409 (84.9)

2. Secondary Outcome

Title	WASO (Wake After Sleep Onset)
Description	WASO (Wake After Sleep Onset): the amount of time test subjects have spent awake after initially falling sleep and before they awaken for good.
Time Frame	2 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Bright Light - AD Patient	Dim Light (Control) - AD Patients	Bright Light - Caregiver	Dim Light (Control) - Caregiver
Arm/Group Description	AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks	AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks	Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks	Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
Measure Participants	31	23	31	23
Mean (Standard Deviation) [units on a scale (minutes)]	124 (111)	107 (110)	63.4 (60.0)	61.0 (64.8)

Adverse Events

Time Frame	5 years
Adverse Event Reporting Description	No serious adverse events.
Arm/Group Title	Bright Light-AD Patients		Dim Light (Control) - AD Patients		Bright Light - Caregivers		Dim Light (Control) - Caregivers
Arm/Group Description	AD patients received bright light		AD patients received dim light in the Control condition		Caregivers received bright light		Caregivers received dim light in the Control condition
All Cause Mortality
	Bright Light-AD Patients		Dim Light (Control) - AD Patients		Bright Light - Caregivers		Dim Light (Control) - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Bright Light-AD Patients		Dim Light (Control) - AD Patients		Bright Light - Caregivers		Dim Light (Control) - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/27 (0%)		0/32 (0%)		0/27 (0%)
Other (Not Including Serious) Adverse Events
	Bright Light-AD Patients		Dim Light (Control) - AD Patients		Bright Light - Caregivers		Dim Light (Control) - Caregivers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/32 (0%)		0/27 (0%)		0/32 (0%)		0/27 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.