| Registry | NCT03441191 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 30 (Actual) |
| Sponsor | University of Washington (Other) |
| Conditions | Insomnia Chronic, Osteoarthritis, Pain, Chronic |
| Interventions | Audiovisual Stimulation (Device) |
| Dates | start 2014-10-01, primary completion 2016-11-01, completion 2016-11-01, first posted 2018-02-22, last updated 2018-02-22 |
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All trials for Insomnia Chronic All trials for Osteoarthritis All trials of Audiovisual Stimulation
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Active AVS | Experimental | Device: Audiovisual Stimulation | 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). |
| Placebo Control AVS | Placebo comparator | Device: Audiovisual Stimulation | 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). |
Sex: All, ages: 60 Years to any
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