Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain

Study Overview
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Brief Summary
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Background and Purpose: The purpose of the study is to test the efficacy of an audio-visual stimulation program for sleep promotion in adults with chronic pain. The hypothesis is that hyper-arousal plays an important role in insomnia. Brainwave entrainment from 8 to 1 Hz reduces arousal, and thereby improves sleep. Improved sleep may change how people perceive pain. Methods: Using a double-blind, randomized controlled trial design, we plan to enroll 30 adults (21-65 years old) experiencing both nonmalignant pain and insomnia. Exclusion criteria include: seizure disorder, sleep disorder, and night shift workers. After a one-week baseline measure, participants will be randomized to intervention or placebo group. Participants in both groups will be asked to self-administer the audio-visual stimulation program every night at bedtime for one month. Upon completion, post intervention measures will be collected.

Detailed Description
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Background: The purpose of this pilot study was to test the efficacy of an open-looped Audio-visual Stimulation program (AVS) for sleep promotion in older adults with osteoarthritis pain. In this study, the AVS program was tested in a randomized controlled design. Specifically, this pilot study examined a 30-minute audio-visual stimulation program that gradually ramped from 10 Hz down to 2 Hz, to be used at bedtime for delta brainwave induction, in a randomized controlled design. The placebo control AVS program consisted of 30-minutes of constant dim light that slowly changed in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range). Method: A total of 30 older adults (mean age 68 ± 5.1, 90% women) with comorbid insomnia and osteoarthritis pain participated in this 2-week study. Participants were randomly assigned to either AVS active program or AVS placebo control program. After the baseline assessment (which included questionnaires [sleep, pain, depression], and quantitative electroencephalogram (QEEG) during AVS induction), participants were asked to self-administer their group specific AVS program nightly at bedtime for two weeks. Post-treatment questionnaires (sleep, pain, depression) were then collected.

Official Title
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Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain

Conditions
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Insomnia Chronic, Osteoarthritis, Pain, Chronic

Intervention / Treatment
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* Device: Audiovisual Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60 years or older Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8) Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4) Exclusion Criteria: Working night shift Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg Syndrome). Seizure disorder Photosensitivity Dementia Diagnosis or other significant chronic illness beyond OA that would impact sleep Severe psychiatric disorder including a history of or current diagnosis of psychosis

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active AVS<br>Active AVS consists of a 30-minute pulsing lights (red, green, blue) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz). | Device: Audiovisual Stimulation<br>* A commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study<br>|
| Placebo Comparator: Placebo Control AVS<br>The placebo control AVS program consists of 30 minutes of constant dim light that slowly changes in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range). | Device: Audiovisual Stimulation<br>* A commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insomnia of Severity Index | A 7-item questionnaire that is a global measure of perceived insomnia severity. Items use a 5-point scale for total scores of 0-28, with >15 considered moderate severity. The ISI has good internal consistency and is sensitive to changes in sleep of older adults in clinical and research. | 2 weeks post baseline | 
| Pittsburgh Sleep Quality Index (PSQI) | Self-rating of overall sleep quality and disturbances using 7 sleep components. A PSQI global score >5 is highly sensitive and specific for distinguishing good and poor sleepers. | 2 weeks post baseline | 
| Brief Pain Inventory (BPI) short form | The BPI is a 9-item questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. | 2 weeks post baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Health Questionnaire | The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale. | 2 weeks post baseline | 
| Sleep Diary | The sleep diary is a two-page sleep log with standard fill in the blank questions about the quantity and quality of the previous night of sleep, including Time to Bed, Sleep Latency, Number of Awakenings, Wake After Sleep Onset time, Total Sleep Time, and Time out of Bed. The diary also includes questions about the causes of sleep difficulties and ratings of daytime fatigue and sleepiness. | baseline through 2 weeks post baseline | 
| Actigraphy | Sleep and wake pattern (actigraph) will be measured by Philips Respironics Actiwatch-2. Actigraphy is a reliable and objective tool to monitor sleep-wake cycles in ambulatory individuals (including older adults) based on frequency and magnitude of movements. | baseline through 2 weeks post baseline | 
| Quantitative Electroencephalogram (QEEG) | Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster)30 with a standard electrode cap that has 22 sensors attaching to the scalp. | baseline |