CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 30 enrolled
Drug / intervention
Audiovisual Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03441191
NCT03441191N/ACompleted

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

University of Washington·interventional·Posted Feb 22, 2018·Updated Feb 22, 2018

In Brief

A clinical study evaluating Audiovisual Stimulation for Insomnia Chronic and 2 related conditions. Completed, enrolled 30 participants.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedFeb 22, 2018
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.4 years ago

Interventions

Audiovisual Stimulationdevice

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