A Dyadic Sleep Intervention for Alzheimer's Disease Patients and Their Caregivers

In 2015, Americans provided 18 billion hours of unpaid care for patients with Alzheimer's
disease (AD) and other dementias, with an economic value of $221 billion. This estimate may
be even higher among caregivers of AD patients when they have sleep problems. In fact, the
caregivers' sleep is often disturbed by nighttime sleep disturbance of AD patients, which is
one of the major reasons why those patients are admitted to institutions. Due to the
bidirectional nature of sleep disturbance in AD patients and their caregivers, it is critical
to develop a sleep intervention program for the dyad that addresses sleep disturbance in both
individuals.

Nighttime sleep disturbance in AD patients is associated with shorter survival, lower quality
of life, and decreased social engagement. Poor sleep among their caregivers is associated
with increased depressive symptoms, higher levels of caregiver role burden, and increased
inflammation, which is known to increase risk for cardiovascular disease. Such decline in
caregivers' health may then impact the quality of care for AD patients.

Behavioral sleep intervention programs for AD patients or caregivers are feasible but
long-term effects on improving sleep and health remain unclear. No behavioral sleep
interventions have focused on the patient-caregiver dyad, and only a few behavioral sleep
intervention studies have targeted community-dwelling AD patients or caregivers. Dyad-based
sleep interventions may have better effects on sleep and other health outcomes because of the
influence of AD patients on their caregivers and vice versa.

The proposed intervention focuses on educating caregivers to improve their own and the
patients' sleep, using behavioral sleep management techniques. This intervention builds upon
a previous caregiver focus group study (VA HSR&D LIP 65-154, PI: Song) and the existing sleep
interventional research studies, which included patients with mild cognitive impairments and
AD patients. The sleep program involves 4 face-to-face meetings plus 1 telephone session.
Phase 1 study aims to iteratively refine and finalize the intervention program materials with
5 AD patient/caregiver dyads. Phase 2 study aims to pilot test the effects of the
intervention program (n=20 dyads) on sleep, health, and quality of life in both members of
the group, compared to a non-directive education-only control program (n=20 dyads) in a small
randomized controlled trial. Primary outcomes will include objective sleep efficiency and
total wake time measured by actigraphy for AD patients and subjective sleep measured by the
Pittsburgh Sleep Quality Index for caregivers. A unique aspect of the proposed study is that
the program is tailored to address sleep problems of both patients and caregivers, and
includes upstream biomarkers to evaluate a key mechanism of intervention benefits that can be
further explored in future research.

Inclusion Criteria for Alzheimer's disease (AD) patients:

- AD diagnosis OR probable or possible AD as documented in electronic medical record,
which includes Mini Mental State Exam score >12 (indicating mild to moderate severity
of AD) and neuroimaging evidence

- Community-dwelling

- >1 sleep problem >3x/week on the Neuropsychiatric Inventory Nighttime Behavior Scale

- Aged >60 years

- Able to ambulate with or without assistive device

- Have an eligible caregiver (see below)

Inclusion Criteria for caregivers:

- Live with an eligible patient

- Aged >21 years

- Have regularly assisted patient with >1 of 6 basic activities of daily living (ADLs)
(i.e., bathing, dressing, toileting, transfers, continence, feeding) or >1 of 8
Instrumental ADL (IADLs) (i.e., using the telephone, shopping, preparing meals,
housekeeping, laundry, transportation, taking medicine, managing money) for the past 6
months

- Pittsburgh Sleep Quality Index (PSQI) total score >5

- Montreal Cognitive Assessment (MoCA) score >= 23

- Can communicate in English

Exclusion Criteria:

- If AD patient is bed bound