Sleep Initiation and Maintenance Disorders
Conditions
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
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.
Interventions
DEVICEBright light
Participants uses bright light
DEVICEControl
Participants uses dim light
Sponsors
Palo Alto Veterans Institute for Research
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time | 2 weeks | The amount of actual sleep time in a sleep episode. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from the local community, from 2004-2008
Pre-assignment details
diagnosis changed for 2 care-recipients, so 2 dyads were not included in the final analysis.
Participants by arm
| Arm | Count |
|---|---|
| Bright Light-AD Patients AD patients received bright light | 31 |
| Dim Light (Control) - AD Patients AD patients received dim light in the Control condition | 23 |
| Bright Light - Caregivers Caregivers received bright light | 31 |
| Dim Light (Control) - Caregivers Caregivers received dim light in the Control condition | 23 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 3 | 0 | 3 |
Baseline characteristics
| Characteristic | Bright Light-AD Patients | Dim Light (Control) - AD Patients | Bright Light - Caregivers | Dim Light (Control) - Caregivers | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 31 Participants | 23 Participants | 31 Participants | 23 Participants | 108 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 0 Participants | 5 Participants | 0 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 23 Participants | 26 Participants | 23 Participants | 100 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 1 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 29 Participants | 22 Participants | 29 Participants | 22 Participants | 102 Participants |
| Region of Enrollment United States | 31 participants | 23 participants | 31 participants | 23 participants | 108 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 22 Participants | 14 Participants | 59 Participants |
| Sex: Female, Male Male | 19 Participants | 12 Participants | 9 Participants | 9 Participants | 49 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 32 | 0 / 27 | 0 / 32 | 0 / 27 |
| serious Total, serious adverse events | 0 / 32 | 0 / 27 | 0 / 32 | 0 / 27 |
Outcome results
Primary
Total Sleep Time
The amount of actual sleep time in a sleep episode.
Time frame: 2 weeks
Population: dyads consisting of 1 AD patient and 1 caregiver
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light - AD Patient | Total Sleep Time | 393 units on a scale (minutes) | Standard Deviation 127 |
| Dim Light (Control) - AD Patients | Total Sleep Time | 420 units on a scale (minutes) | Standard Deviation 125 |
| Bright Light - Caregiver | Total Sleep Time | 398 units on a scale (minutes) | Standard Deviation 65.4 |
| Dim Light (Control) - Caregiver | Total Sleep Time | 409 units on a scale (minutes) | Standard Deviation 84.9 |
Secondary
WASO (Wake After Sleep Onset)
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bright Light - AD Patient | WASO (Wake After Sleep Onset) | 124 units on a scale (minutes) | Standard Deviation 111 |
| Dim Light (Control) - AD Patients | WASO (Wake After Sleep Onset) | 107 units on a scale (minutes) | Standard Deviation 110 |
| Bright Light - Caregiver | WASO (Wake After Sleep Onset) | 63.4 units on a scale (minutes) | Standard Deviation 60 |
| Dim Light (Control) - Caregiver | WASO (Wake After Sleep Onset) | 61.0 units on a scale (minutes) | Standard Deviation 64.8 |