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

NCT03441191 | Completed

• 1 other identifier: 48538
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Insomnia Chronic; Osteoarthritis; Pain, Chronic

Outcome Measures

Primary Outcomes (3)

• Insomnia of Severity Index

  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)

  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

  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 Outcomes (4)

• 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

Study Arms (2)

Active AVS

EXPERIMENTAL

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

Placebo Control AVS

PLACEBO COMPARATOR

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

Interventions

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

Active AVS; Placebo Control AVS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Having difficulty sleeping over the past three months (Insomnia Severity Index ≥ 8)
• Having osteoarthritis pain (Brief Pain Inventory Worst pain ≥ 4)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead

Related Publications (3)

• 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.

  PMID: 25931250 BACKGROUND

• 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.

  PMID: 25257144 BACKGROUND

• 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.

  PMID: 26294268 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Osteoarthritis; Chronic Pain

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Tang, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Nursing: Department Of Psychosocial And Community Health

Study Record Dates

• First Submitted: February 15, 2018
• First Posted: February 22, 2018
• Study Start: October 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: February 22, 2018

Record last verified: 2018-02