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

NCT ID: NCT03441191

Last Updated: 2018-02-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-01
• Study Completion Date: 2016-11-01

Brief Summary

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.

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.

Conditions

Insomnia Chronic; Osteoarthritis; Pain, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Audiovisual Stimulation

Intervention Type: 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

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).

Group Type: PLACEBO_COMPARATOR

Audiovisual Stimulation

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Jean Tang

Assistant Professor, Nursing: Department Of Psychosocial And Community Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jean Tang, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

References

Tang HY, Vitiello MV, Perlis M, Riegel B. Open-Loop Neurofeedback Audiovisual Stimulation: A Pilot Study of Its Potential for Sleep Induction in Older Adults. Appl Psychophysiol Biofeedback. 2015 Sep;40(3):183-8. doi: 10.1007/s10484-015-9285-x.

Reference Type: BACKGROUND

PMID: 25931250 (View on PubMed)

Tang HY, Vitiello MV, Perlis M, Mao JJ, Riegel B. A pilot study of audio-visual stimulation as a self-care treatment for insomnia in adults with insomnia and chronic pain. Appl Psychophysiol Biofeedback. 2014 Dec;39(3-4):219-25. doi: 10.1007/s10484-014-9263-8.

Reference Type: BACKGROUND

PMID: 25257144 (View on PubMed)

Tang HY, Riegel B, McCurry SM, Vitiello MV. Open-Loop Audio-Visual Stimulation (AVS): A Useful Tool for Management of Insomnia? Appl Psychophysiol Biofeedback. 2016 Mar;41(1):39-46. doi: 10.1007/s10484-015-9308-7.

Reference Type: BACKGROUND

PMID: 26294268 (View on PubMed)

Other Identifiers

48538

Identifier Type: -

Identifier Source: org_study_id