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

University of Washington

Status: Completed

Conditions: Osteoarthritis; Pain, Chronic; Insomnia Chronic

Treatments: Device: Audiovisual Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT03441191

48538

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups, including a placebo group

Active AVS

Experimental group

Description:

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).

Treatment:

Device: Audiovisual Stimulation

Placebo Control AVS

Placebo Comparator group

Description:

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).

Treatment:

Device: Audiovisual Stimulation