Audio-visual Stimulation: Sleep Dose Response

Osteoarthritis (OA) affects 50% of older adults. Common comorbidities associated with OA
include poor sleep, pain, depression, and fatigue. OA patients with insomnia tend to report
greater pain than those without insomnia. A recent systematic review concluded that sleep
disturbance is a stronger predictor of chronic pain than vice versa. Standard treatment
options for insomnia are medication and Cognitive Behavioral Therapy for Insomnia (CBT-I).
Prescription medication has good short term efficacy but benefits do not persist after
treatment discontinuation and there are notable side effects. Treatment effects for CBT-I are
comparable to or exceed those for medications, and have been shown efficacious for persons
with OA pain. However, CBT-I practitioners are not yet available in many healthcare systems.
New, effective, and easy-to-use self-management alternatives could greatly help reduce the
burden of insomnia and potentially decrease pain, depression, and fatigue in individuals with
OA. We propose to test a novel, easily-used, self-management intervention to improve
OA-related insomnia, pain, depression and fatigue: open-loop neurofeedback Audio Visual
Stimulation (AVS). AVS uses preprogrammed light and sound patterns to evoke brainwave
potentials at pre-set designated frequencies. The AVS intervention consists of 30 minutes of
light and sound pulsing stimuli that gradually descend from alpha (10 Hz) to delta (2 Hz)
frequencies. AVS placebo consists of 30 minutes of constant dim light slowly changing in
color, and a steady monotone at ultra-low frequency (below 1 Hz). This proposed study builds
upon our successful completion of three pilot studies using AVS. Based on the pilot findings,
we hypothesize that the use of active AVS at bedtime induces delta brainwaves, but additional
testing is needed to determine how long AVS should be used to produce significant
improvements in subjective sleep quality relative to placebo control. In addition, we propose
to experimentally test the effect of blue light, which is known to suppress melatonin
production, as a potential confounding variable in the AVS intervention. We propose a trial
of AVS in 75 community dwelling older adults with chronic comorbid insomnia and OA pain.
After baseline assessment, participants will be randomized to 3 groups: AVS-1 (red, green &
blue light) vs. AVS-2 (red & green light only) vs. placebo AVS. Participants will
self-administer AVS at bedtime nightly for one month. QEEG will be measured at baseline, and
then at 2, 3 and 4 weeks to evaluate neurological responses to AVS over time. Insomnia
severity will be similarly assessed to determine the most efficacious AVS treatment duration
and color array for improving insomnia symptoms. OA-related symptoms (pain, depression, and
fatigue) and objective sleep outcomes will also be assessed. Data will inform a definitive
RCT of AVS for insomnia and relative OA symptoms.

Inclusion Criteria:

- Age 60+ with insomnia and nonmalignant OA pain most days

- Insomnia Severity Index (ISI): >= 12

- Sleep problems >=3 times per week for >=6 months

- Brief Pain Inventory (BPI): average pain >=4 and < 10

- Osteoarthritis pain for >=6 months;

- Blessed Telephone Information-Memory-Concentration Test (TIMC) < 7

- Presence of sleep onset complaint (latency >30 minutes on PSQI and ISI sub-scales);
may also have sleep maintenance or early morning awakening complaints

Exclusion Criteria:

- Seizure disorder

- Migraine

- Photosensitivity

- Prior diagnosis of a primary sleep disorder

- Sleep apnea with an AHI/RDI score >=5 or current use of a CPAP machine

- Periodic leg movement disorder

- Restless leg syndrome

- Rapid eye movement behavior disorder

- Sleep-wake cycle disturbance

- Unusual sleep schedule (i.e. shift worker)

- 400 mg daily caffeine intake (4 cups of 8 oz brewed coffee/tea)

- 3 or more alcoholic drinks/day

- Diagnosis of: rheumatoid arthritis

- Terminal disease, pending major surgery

- Active chemotherapy or radiation for cancer

- Inpatient treatment for congestive heart failure within the previous 6 months

- Dementia diagnosis

- Use of acetylcholinesterase inhibitor and/or memantine for cognitive impairmen

- Use of psychoactive medications (stimulants, sedative hypnotics, anxiolytics,
antipsychotics) or recreational drugs including marijuana.