Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
CompletedNot applicableNCT03441191
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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)
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.
Study details
- Official title
- Audio-visual Stimulation for Sleep Promotion in Older Adults With Osteoarthritis Pain
- Conditions
- Insomnia Chronic
- Osteoarthritis
- Pain, Chronic
- Interventions
- Device: Audiovisual Stimulation
- Sponsor
- University of Washington
- Start date
- 2014-10-01
- Primary completion
- 2016-11-01
- Sex
- All
- Age range
- from 60 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03441191