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

February 20, 2018 updated by: Jean Tang, University of Washington

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Device: Audiovisual Stimulation
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
Placebo Comparator: 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).
Device: Audiovisual Stimulation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks post baseline
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.
2 weeks post baseline
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.
2 weeks post baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 weeks post baseline
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.
baseline through 2 weeks post baseline
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.
baseline through 2 weeks post baseline
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.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Washington

Investigators

  • Principal Investigator: Jean Tang, PhD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2014

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

February 15, 2018

First Submitted That Met QC Criteria

February 20, 2018

First Posted (Actual)

February 22, 2018

Study Record Updates

Last Update Posted (Actual)

February 22, 2018

Last Update Submitted That Met QC Criteria

February 20, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 48538

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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