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Insomnia ChronicNCT03441191

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

A study testing Audiovisual Stimulation in people with Insomnia Chronic and Osteoarthritis, run by University of Washington.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Insomnia Chronic, Osteoarthritis, Pain, Chronic
What is being tested?
Audiovisual Stimulation
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
No sites listed yet
Study dates
1 Oct 2014to 1 Nov 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

About this study

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.

Read the detailed description

Background: The purpose of this pilot study was to test the efficacy of an open-looped Audio-visual Stimulation program (AVS) for sleep promotion in older adults with osteoarthritis pain. In this study, the AVS program was tested in a randomized controlled design. Specifically, this pilot study examined a 30-minute audio-visual stimulation program that gradually ramped from 10 Hz down to 2 Hz, to be used at bedtime for delta brainwave induction, in a randomized controlled design. The placebo control AVS program consisted of 30-minutes of constant dim light that slowly changed in color, and a steady monotone at ultra-low (<1 Hz) frequency (outside of the entrainment range).

Method: A total of 30 older adults (mean age 68 ± 5.1, 90% women) with comorbid insomnia and osteoarthritis pain participated in this 2-week study. Participants were randomly assigned to either AVS active program or AVS placebo control program. After the baseline assessment (which included questionnaires [sleep, pain, depression], and quantitative electroencephalogram (QEEG) during AVS induction), participants were asked to self-administer their group specific AVS program nightly at bedtime for two weeks. Post-treatment questionnaires (sleep, pain, depression) were then collected.

Being tested
Audiovisual Stimulation
Medical subject headings
Sleep Initiation and Maintenance Disorders, Osteoarthritis, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03441191
Study groupRoleWhat they receive
Active AVSExperimentalActive AVS consists of a 30-minute pulsing lights (red, green, blue) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz).
Receives: Device: Audiovisual Stimulation
Placebo Control AVSPlacebo comparatorThe 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).
Receives: Device: Audiovisual Stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks post baseline

  2. Pittsburgh Sleep Quality Index (PSQI)

    Self-rating of overall sleep quality and disturbances using 7 sleep components. A PSQI global score >5 is highly sensitive and specific for distinguishing good and poor sleepers.

    Measured: 2 weeks post baseline

  3. Brief Pain Inventory (BPI) short form

    The BPI is a 9-item questionnaire that assesses severity of pain, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week.

    Measured: 2 weeks post baseline

Secondary outcomes (4)

  1. Patient Health Questionnaire

    The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale.

    Measured: 2 weeks post baseline

  2. Sleep Diary

    The sleep diary is a two-page sleep log with standard fill in the blank questions about the quantity and quality of the previous night of sleep, including Time to Bed, Sleep Latency, Number of Awakenings, Wake After Sleep Onset time, Total Sleep Time, and Time out of Bed. The diary also includes questions about the causes of sleep difficulties and ratings of daytime fatigue and sleepiness.

    Measured: baseline through 2 weeks post baseline

  3. Actigraphy

    Sleep and wake pattern (actigraph) will be measured by Philips Respironics Actiwatch-2. Actigraphy is a reliable and objective tool to monitor sleep-wake cycles in ambulatory individuals (including older adults) based on frequency and magnitude of movements.

    Measured: baseline through 2 weeks post baseline

  4. Quantitative Electroencephalogram (QEEG)

    Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster)30 with a standard electrode cap that has 22 sensors attaching to the scalp.

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2018
  2. Study start1 Oct 2014
  3. Primary completion1 Nov 2016
  4. Study completion1 Nov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03441191
Sponsor's protocol ID
48538
Status last verified
Feb 2018
First submitted
15 Feb 2018
Last updated
22 Feb 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25931250

  • 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.

    PubMed 25257144

  • 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.

    PubMed 26294268

Questions about this trial

What is this clinical trial studying?

A study testing Audiovisual Stimulation in people with Insomnia Chronic and Osteoarthritis, run by University of Washington.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Insomnia of Severity Index (time frame: 2 weeks post baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03441191, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2018.

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