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

This study has been completed.
Sponsor:
Collaborator:
Palo Alto Veterans Institute for Research
Information provided by (Responsible Party):
Jerome A Yesavage,, Stanford University
ClinicalTrials.gov Identifier:
NCT00946530
First received: July 23, 2009
Last updated: February 9, 2017
Last verified: December 2016
Results First Received: December 5, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Outcomes Assessor;   Primary Purpose: Treatment
Condition: Sleep Initiation and Maintenance Disorders
Interventions: Device: Bright light
Device: Control

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from the local community, from 2004-2008

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.

Reporting Groups
  Description
Bright Light - AD Patient AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
Dim Light (Control) - AD Patients AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
Bright Light - Caregiver Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
Dim Light (Control) - Caregiver Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks

Participant Flow:   Overall Study
    Bright Light - AD Patient   Dim Light (Control) - AD Patients   Bright Light - Caregiver   Dim Light (Control) - Caregiver
STARTED   32 [1]   27 [2]   32 [1]   27 [2] 
COMPLETED   31 [3]   23 [4]   31 [3]   23 [5] 
NOT COMPLETED   1   4   1   4 
Withdrawal by Subject                0                3                0                3 
Physician Decision                1                1                1                1 
[1] 32 dyads consisting of 1 AD patient and 1 caregiver were assigned the Bright Light Arm
[2] 27 dyads consisting of 1 AD patient and 1 caregiver were assigned to the Dim Light (Control) arm
[3] 31 dyads consisting of 1 AD patient and 1 caregiver completed the Bright Light Arm
[4] 23 dyads consisting of 1 AD patient and 1 caregiver completed to the Dim Light (Control) arm
[5] 23 dyads consisting of 1 AD patient and 1 caregiver were assigned to the Dim Light (Control) arm



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Memory impaired older adults and their caregivers

Reporting Groups
  Description
Bright Light-AD Patients AD patients received bright light
Dim Light (Control) - AD Patients AD patients received dim light
Bright Light - Caregivers Caregivers received bright light
Dim Light (Control) - Caregivers Caregivers received dim light
Total Total of all reporting groups

Baseline Measures
   Bright Light-AD Patients   Dim Light (Control) - AD Patients   Bright Light - Caregivers   Dim Light (Control) - Caregivers   Total 
Overall Participants Analyzed 
[Units: Participants]
 31   23   31   23   108 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
>=65 years      31 100.0%      23 100.0%      31 100.0%      23 100.0%      108 100.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      12  38.7%      11  47.8%      22  71.0%      14  60.9%      59  54.6% 
Male      19  61.3%      12  52.2%      9  29.0%      9  39.1%      49  45.4% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      3   9.7%      0   0.0%      5  16.1%      0   0.0%      8   7.4% 
Not Hispanic or Latino      28  90.3%      23 100.0%      26  83.9%      23 100.0%      100  92.6% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      0   0.0%      0   0.0%      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   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      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   0.0%      0   0.0% 
Unknown or Not Reported      1   3.2%      0   0.0%      1   3.2%      0   0.0%      2   1.9% 
Region of Enrollment 
[Units: Participants]
         
United States   31   23   31   23   118 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Total Sleep Time   [ Time Frame: 2 weeks ]

2.  Secondary:   WASO (Wake After Sleep Onset)   [ Time Frame: 2 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jerome A. Yesavage, MD
Organization: Stanford University
phone: 650-493-5000 ext x64330
e-mail: yesavage@stanford.edu


Publications of Results:

Responsible Party: Jerome A Yesavage,, Stanford University
ClinicalTrials.gov Identifier: NCT00946530     History of Changes
Other Study ID Numbers: SU-06302009-2840
1677 ( Other Identifier: Stanford University IRB )
Study First Received: July 23, 2009
Results First Received: December 5, 2013
Last Updated: February 9, 2017