Clinical trial NCT03569865: Audio-visual Stimulation: Sleep Dose Response
Official title: Audio-visual Stimulation: Sleep Dose Response
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Osteoarthritis
Pain, Chronic
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2018-06-26
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This study examines the impact of an innovative audiovisual stimulation (AVS) program on human brainwaves, and its usefulness to improve sleep. The AVS intervention, if demonstrated to be efficacious for sleep promotion, could benefit millions of people worldwide.

Detailed description: 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.

Eligibility criteria: 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 OR 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.

Primary outcomes:
measure: Insomnia of Severity Index
timeFrame: Baseline through 4 weeks post baseline
measure: Quantitative Electroencephalogram (QEEG)
timeFrame: Baseline through 4 weeks post baseline
Secondary outcomes:
measure: Actigraphy
timeFrame: Baseline through 4 weeks post baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline through 4 weeks post baseline
measure: Brief Pain Inventory (BPI) short form
timeFrame: Baseline through 4 weeks post baseline
measure: Patient Health Questionnaire
timeFrame: Baseline through 4 weeks post baseline
measure: Sleep Diary
timeFrame: Baseline through 4 weeks post baseline
measure: Flinders Fatigue Scale
timeFrame: A 7-item self-report questionnaire to measure fatigue level in a variety of situations. It has strong internal reliability and validity, and been used to measure fatigue with older adults
measure: General Anxiety Disorder-7
timeFrame: Baseline through 4 weeks post baseline
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Jean Tang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tang HY, Vitiello MV, Perlis M, Riegel B. Open-Loop Neurofeedback Audiovisual Stimulation: A Pilot Study of Its Potential for Sleep Induction in Older Adults. Appl Psychophysiol Biofeedback. 2015 Sep;40(3):183-8. doi: 10.1007/s10484-015-9285-x.
citation: Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):219-25. doi: 10.1007/s10484-014-9263-8.
citation: Tang HY, Riegel B, McCurry SM, Vitiello MV. Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7.