Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Insomnia of Severity Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Working night shift
- •Previously diagnosed with a primary sleep disorder (Sleep Apnea or Restless Leg Syndrome).
- •Seizure disorder
- •Photosensitivity
- •Diagnosis or other significant chronic illness beyond OA that would impact sleep
- •Severe psychiatric disorder including a history of or current diagnosis of psychosis
研究组 & 干预措施
Active AVS
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).
干预措施: Audiovisual Stimulation (Device)
Placebo Control AVS
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).
干预措施: Audiovisual Stimulation (Device)
结局指标
主要结局
Insomnia of Severity Index
时间窗: 2 weeks post baseline
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.
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 2 weeks post baseline
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.
Brief Pain Inventory (BPI) short form
时间窗: 2 weeks post baseline
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.
次要结局
- Patient Health Questionnaire(2 weeks post baseline)
- Sleep Diary(baseline through 2 weeks post baseline)
- Actigraphy(baseline through 2 weeks post baseline)
- Quantitative Electroencephalogram (QEEG)(baseline)
研究者
Jean Tang
Assistant Professor, Nursing: Department Of Psychosocial And Community Health
University of Washington