Audio-visual Stimulation: Sleep Dose Response

NCT03569865 | Completed

• 2 other identifiers: STUDY000050841R21NR017446-01A1
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

Osteoarthritis (OA) pain affects 50 percent of older adults, more than half of whom also experience significant sleep disturbance. This study examines the impact of an innovative audiovisual stimulation (AVS) program on human brainwaves, and its usefulness to improve sleep. The AVS intervention, if demonstrated to be efficacious for sleep promotion, could benefit millions of people worldwide.

Conditions

Insomnia Chronic; Osteoarthritis; Pain, Chronic

Outcome Measures

Primary Outcomes (2)

• 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.

  Baseline through 4 weeks post baseline

• Quantitative Electroencephalogram (QEEG)

  Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster) with a standard electrode cap that has 22 sensors attaching to the scalp.

  Baseline through 4 weeks post baseline

Secondary Outcomes (7)

• Actigraphy

  Baseline through 4 weeks post baseline

• Pittsburgh Sleep Quality Index (PSQI)

  Baseline through 4 weeks post baseline

• Brief Pain Inventory (BPI) short form

  Baseline through 4 weeks post baseline

• Patient Health Questionnaire

  Baseline through 4 weeks post baseline

• Sleep Diary

  Baseline through 4 weeks post baseline

Study Arms (3)

Active AVS-1

EXPERIMENTAL

Active AVS-1 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

Active AVS-2

EXPERIMENTAL

Active AVS-2 consists of a 30-minute pulsing lights (red, green) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz).

Device: Audiovisual Stimulation

Placebo 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-1; Active AVS-2; Placebo AVS

Eligibility Criteria

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

You may qualify if:

• Age 60+ with insomnia and nonmalignant OA pain most days
• Insomnia Severity Index (ISI): \>= 12
• Sleep problems \>=3 times per week for \>=6 months
• Brief Pain Inventory (BPI): average pain \>=4 and \< 10
• Osteoarthritis pain for \>=6 months;
• Blessed Telephone Information-Memory-Concentration Test (TIMC) \< 7
• Presence of sleep onset complaint (latency \>30 minutes on PSQI OR ISI sub-scales); may also have sleep maintenance or early morning awakening complaints

You may not qualify if:

• Seizure disorder
• Migraine
• Photosensitivity
• Prior diagnosis of a primary sleep disorder
• Sleep apnea with an AHI/RDI score \>=5 or current use of a CPAP machine
• Periodic leg movement disorder
• Restless leg syndrome
• Rapid eye movement behavior disorder
• Sleep-wake cycle disturbance
• Unusual sleep schedule (i.e. shift worker)
• mg daily caffeine intake (4 cups of 8 oz brewed coffee/tea)
• or more alcoholic drinks/day
• Diagnosis of: rheumatoid arthritis
• Terminal disease, pending major surgery
• Active chemotherapy or radiation for cancer

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

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 RESULT

• 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 RESULT

• 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 RESULT

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: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 15, 2018
• First Posted: June 26, 2018
• Study Start: March 15, 2019
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: January 20, 2022

Record last verified: 2022-01

Locations

US (1)