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
- Insomnia Chronic
- Osteoarthritis
- Pain, Chronic
- 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