Alzheimer's Disease
Conditions
Brief summary
To test the effect of a tailored lighting intervention controlled by the Readings At Desk (RAD) controller on sleep and mood in Alzheimer's disease participants.
Detailed description
Each participant will be enrolled for 22 weeks. Participants will be randomly assigned to receive either the active or control lighting condition. Each lighting condition will be 8 weeks in length. After a 4 week washout, each participant will crossover to the opposite condition. Assessments will be performed before and at the end of each lighting intervention.
Interventions
Lighting intervention designed to impact the circadian system
Lighting intervention designed to have no impact on the circadian system
Sponsors
Icahn School of Medicine at Mount Sinai
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Participants will randomly be assigned to initially receive the active or control lighting intervention
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of Alzheimer's disease with a Mini Mental Score Examination (MMSE) between 0 and 19 * a score \>5 on the PSQI.
Exclusion criteria
\- use of sleep medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Disturbance Using the Pittsburgh Sleep Quality Index (PSQI) | Baseline and post intervention (8 weeks) | The Pittsburgh Sleep Quality Index (PSQI) is composed of 19 items that generate 7 component scores. The sum of the 7 component scores yields a single global score with a range of 0 to 21. A global score \>5 is considered to indicate sleep disturbances. A lower global score indicates improvement in sleep disturbance. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression Screening Utilizing the Cornell Scale for Depression in Dementia (CSDD) | Baseline and post intervention (8 weeks) | The CSDD is a 19-item tool designed to rate symptoms of depression in patients with dementia. This tool evaluates the presence and extent of mood-related signs. Scores range from 0 to 38 with a higher score indicating higher depressive symptoms. |
| Sleep Efficiency Measured by Actigraphy | Baseline and post intervention (8 weeks) | Sleep efficiency is calculated from the wrist worn actigraph by the software program as the percentage of the time in bed spent sleeping. The ratio of total sleep time (TST) to total time in bed (TIB) multiplied by 100 to yield a percentage. |
| Sleep Burden Using The Sleep Disorders Inventory (SDI) | Baseline and post intervention (8 weeks) | Full scale from 0 to 56, with higher score indicating greater sleep disturbance |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMariana Figueiro, PhD
Mount Sinai Icahn School of Medicine
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 84.2 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 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 | 0 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 | 14 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 11 |
| other Total, other adverse events | 0 / 11 | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 | 0 / 11 |
Outcome results
None listed