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Completed

NCT Number: NCT03441191

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

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.

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Key information

Conditions

Insomnia Chronic Arthritis Chronic Pain Dyssomnias Joint Diseases Mental Disorders Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Osteoarthritis Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audiovisual Stimulation

Device

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

Primary outcomes

  1. Insomnia of Severity Index

    Time frame: 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.

  2. Pittsburgh Sleep Quality Index (PSQI)

    Time frame: 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.

  3. Brief Pain Inventory (BPI) short form

    Time frame: 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.

Secondary outcomes

  1. Patient Health Questionnaire

    Time frame: 2 weeks post baseline

    The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale.

  2. Sleep Diary

    Time frame: baseline through 2 weeks post baseline

    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.

  3. Actigraphy

    Time frame: baseline through 2 weeks post baseline

    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.

  4. Quantitative Electroencephalogram (QEEG)

    Time frame: baseline

    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.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Feb 22, 2018
Registry last updated
Feb 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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