Clinical trial NCT03441191: Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
Official title: Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia Chronic
Osteoarthritis
Pain, Chronic
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 30
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: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Insomnia of Severity Index
timeFrame: 2 weeks post baseline
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks post baseline
measure: Brief Pain Inventory (BPI) short form
timeFrame: 2 weeks post baseline
Secondary outcomes:
measure: Patient Health Questionnaire
timeFrame: 2 weeks post baseline
measure: Sleep Diary
timeFrame: baseline through 2 weeks post baseline
measure: Actigraphy
timeFrame: baseline through 2 weeks post baseline
measure: Quantitative Electroencephalogram (QEEG)
timeFrame: baseline
Other outcomes:
Locations:
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.