Depression, Sleep Disturbances
Conditions
Keywords
light treatment, circadian rhythms, sleep, agitation, depression
Brief summary
Tailored light treatment will increase sleep efficiency, reduce depression and reduce agitation scores in those with Alzheimer's disease and related dementia
Detailed description
In a within subjects, randomized placebo control study, a tailored light treatment will be used for short-term (4 weeks). Outcome measures include sleep measures (actigraphy), and questionnaires probing behavior and mood in those who have been diagnosed with Alzheimer's disease and related dementia. After a 4-week washout period, a placebo control inactive light will be used for another 4 weeks.
Interventions
OTHERHigh Active intervention
The active intervention is a bluish white light source delivering at least 500 lux at the eye of the patient during at least 2 hours daily.
OTHERInactive intervention
The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
OTHERMid Level Active Intervention
The Mid level active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* mild to moderate Alzheimer's disease and related dementia (ADRD)
Exclusion criteria
* major organ failure, * major illness, * history of head injury, * hypertension or diabetes, * use psychotropic (sleep aid) medicine, obstructing cataracts, macular degeneration, and blindness
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pittsburgh Sleep Quality Index (PSQI) | Change from Baseline (week 0) and intervention (week 4) | Caregivers (on behalf of subjects who cannot complete) and subjects are asked to complete the Pittsburgh Sleep Quality Index (PSQI), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The seven component scores are summed to provide a global score ranging from 0 to 21 and a score of 5 or above indicates sleep disturbance. A higher number indications a greater sleep disturbance |
| Cohen-Mansfield Agitation Inventory (CMAI) | Change from Baseline (week 0) and intervention (week 4) | Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out the Cohen-Mansfield Agitation Score, which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. 29 item instrument, each item scored 1-7. Total range score from 29-203 - a higher score indicates more agitation |
| Cornell Scale for Depression in Dementia (CSDD) Questionnaire | Change from Baseline (week 0) and intervention (week 4) | Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective questionnaires assessing depression using the Cornell Scale for Depression in Dementia (CSDD) Questionnaires are assessed at baseline and after 4 weeks they are exposed to the lighting intervention. The CSDD consists of 19 questions rated on a scale of 0 to 2 with all scores summed for a total score range 0-38. A score greater than 12 indicates depression and a higher score indicates greater depression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Activity of Daily Living Questionnaire (MDS-ADL) | Change from Baseline (week 0) and intervention (week 4) | Caregivers (on behalf of subjects who cannot complete) and subjects are asked to fill out subjective Activity of Daily Living questionnaire (MDS-ADL), which is assessed at baseline and after 4 weeks they are exposed to the lighting intervention. Scores range from 4 to 18 and a higher score indicates a higher dependence. |
| Circadian Stimulus Dose | Change from Baseline (week 0) and intervention (week 4) | Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. These data are used to determine circadian disruption (correlation between light/dark and activity/rest) and light dose. Circadian stimulus (CS) is the amount of light needed to activate the circadian system. The range is 0 to 0.6 the higher the number the greater the CS dose |
| Sleep Efficiency Score | Change from Baseline (week 0) and intervention (week 4) | Subjects are asked to wear an actigraph to obtain activity/rest patterns for 7 days prior to intervention and for 7 days after 3 weeks that the light treatment is applied. Actigraphs are used to measure sleep efficiency. Full scale score from 0-100, higher score indicates better efficiency. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana G Figueiro, PhD
Icahn School of Medicine at Mount Sinai
Participant flow
Pre-assignment details
Participants experienced each of the conditions
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 80.4 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 35 Participants |
| Sex: Female, Male Female | 38 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 31 | 0 / 31 |
| other Total, other adverse events | 0 / 31 | 0 / 31 | 0 / 31 |
| serious Total, serious adverse events | 0 / 31 | 0 / 31 | 0 / 31 |
Outcome results
None listed