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Audio-visual Stimulation: Sleep Dose Response

CompletedNot applicableNCT03569865
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Audio-visual Stimulation: Sleep Dose Response
Conditions
Interventions
  • Device: Audiovisual Stimulation
Sponsor
University of Washington
Collaborators
National Institute of Nursing Research (NINR)
Start date
2019-03-15
Primary completion
2020-10-31
Sex
All
Age range
from 60 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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 Exclusion Criteria: * 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) * 400 mg daily caffeine intake (4 cups of 8 oz brewed coffee/tea) * 3 or more alcoholic drinks/day * Diagnosis of: rheumatoid arthritis * Terminal disease, pending major surgery * Active chemotherapy or radiation for cancer * Inpatient treatment for congestive heart failure within the previous 6 months * Dementia diagnosis * Use of acetylcholinesterase inhibitor and/or memantine for cognitive impairmen * Use of psychoactive medications (stimulants, sedative hypnotics, anxiolytics, antipsychotics) or recreational drugs including marijuana.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03569865