Insomnia ChronicNCT03569865
Audio-visual Stimulation: Sleep Dose Response
A study testing Audiovisual Stimulation in people with Insomnia Chronic and Osteoarthritis, run by University of Washington at 1 site in United States.
Trial summary
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. 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
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 31 Oct 2020
- 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
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Osteoarthritis (OA) affects 50% of older adults. Common comorbidities associated with OA include poor sleep, pain, depression, and fatigue. OA patients with insomnia tend to report greater pain than those without insomnia. A recent systematic review concluded that sleep disturbance is a stronger predictor of chronic pain than vice versa. Standard treatment options for insomnia are medication and Cognitive Behavioral Therapy for Insomnia (CBT-I). Prescription medication has good short term efficacy but benefits do not persist after treatment discontinuation and there are notable side effects. Treatment effects for CBT-I are comparable to or exceed those for medications, and have been shown efficacious for persons with OA pain. However, CBT-I practitioners are not yet available in many healthcare systems. New, effective, and easy-to-use self-management alternatives could greatly help reduce the burden of insomnia and potentially decrease pain, depression, and fatigue in individuals with OA. We propose to test a novel, easily-used, self-management intervention to improve OA-related insomnia, pain, depression and fatigue: open-loop neurofeedback Audio Visual Stimulation (AVS). AVS uses preprogrammed light and sound patterns to evoke brainwave potentials at pre-set designated frequencies. The AVS intervention consists of 30 minutes of light and sound pulsing stimuli that gradually descend from alpha (10 Hz) to delta (2 Hz) frequencies. AVS placebo consists of 30 minutes of constant dim light slowly changing in color, and a steady monotone at ultra-low frequency (below 1 Hz). This proposed study builds upon our successful completion of three pilot studies using AVS. Based on the pilot findings, we hypothesize that the use of active AVS at bedtime induces delta brainwaves, but additional testing is needed to determine how long AVS should be used to produce significant improvements in subjective sleep quality relative to placebo control. In addition, we propose to experimentally test the effect of blue light, which is known to suppress melatonin production, as a potential confounding variable in the AVS intervention. We propose a trial of AVS in 75 community dwelling older adults with chronic comorbid insomnia and OA pain. After baseline assessment, participants will be randomized to 3 groups: AVS-1 (red, green \& blue light) vs. AVS-2 (red \& green light only) vs. placebo AVS. Participants will self-administer AVS at bedtime nightly for one month. QEEG will be measured at baseline, and then at 2, 3 and 4 weeks to evaluate neurological responses to AVS over time. Insomnia severity will be similarly assessed to determine the most efficacious AVS treatment duration and color array for improving insomnia symptoms. OA-related symptoms (pain, depression, and fatigue) and objective sleep outcomes will also be assessed. Data will inform a definitive RCT of AVS for insomnia and relative OA symptoms.
- Conditions
- Insomnia Chronic, Osteoarthritis, Pain, Chronic
- 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 group | Role | What they receive |
|---|---|---|
| Active AVS-1 | Experimental | Active AVS-1 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 |
| Active AVS-2 | Experimental | Active AVS-2 consists of a 30-minute pulsing lights (red, green) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz). Receives: Device: Audiovisual Stimulation |
| Placebo AVS | Placebo comparator | The 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.
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: Baseline through 4 weeks post baseline
Quantitative Electroencephalogram (QEEG)
Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster) with a standard electrode cap that has 22 sensors attaching to the scalp.
Measured: Baseline through 4 weeks post baseline
Secondary outcomes (7)
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 4 weeks post baseline
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: Baseline through 4 weeks post baseline
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: Baseline through 4 weeks post baseline
Patient Health Questionnaire
The PHQ-9 is a 9-item reliable, valid, measure that rates depression symptom severity on a 4-point scale.
Measured: Baseline through 4 weeks post baseline
Sleep Diary
A 7-day diary including: bed and rise times, number of nighttime awakenings, total wake time, and morning refreshment. Participants will also report sleep and pain medication, subjective sleep quality, and pain.
Measured: Baseline through 4 weeks post baseline
Flinders Fatigue Scale
A 7-item self-report questionnaire to measure fatigue level in a variety of situations. It has strong internal reliability and validity, and been used to measure fatigue with older adults.
Measured: A 7-item self-report questionnaire to measure fatigue level in a variety of situations. It has strong internal reliability and validity, and been used to measure fatigue with older adults
General Anxiety Disorder-7
A 7-item self-report questionnaire to measure anxiety level in a variety of situations.
Measured: Baseline through 4 weeks post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start15 Mar 2019
- Primary completion31 Oct 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Insomnia ChronicStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Jean Tang, University of Washington
- Investigators
- Jean Tang, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03569865
- Sponsor's protocol ID
- STUDY00005084
- Other IDs
- 1R21NR017446-01A1
- Status last verified
- Jan 2022
- First submitted
- 15 Jun 2018
- Last updated
- 20 Jan 2022
- 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 25931250Tang 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 25257144Tang 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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audio-visual Stimulation: Sleep Dose Response
- ClinicalTrials.gov ID
- NCT03569865
- Acronym / sponsor ID
- STUDY00005084
- Conditions
- Insomnia Chronic, Osteoarthritis, Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 31 Oct 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Osteoarthritis (OA) affects 50% of older adults. Common comorbidities associated with OA include poor sleep, pain, depression, and fatigue. OA patients with insomnia tend to report greater pain than those without insomnia. A recent systematic review concluded that sleep disturbance is a stronger predictor of chronic pain than vice versa. Standard treatment options for insomnia are medication and Cognitive Behavioral Therapy for Insomnia (CBT-I). Prescription medication has good short term efficacy but benefits do not persist after treatment discontinuation and there are notable side effects. Treatment effects for CBT-I are comparable to or exceed those for medications, and have been shown efficacious for persons with OA pain. However, CBT-I practitioners are not yet available in many healthcare systems. New, effective, and easy-to-use self-management alternatives could greatly help reduce the burden of insomnia and potentially decrease pain, depression, and fatigue in individuals with OA. We propose to test a novel, easily-used, self-management intervention to improve OA-related insomnia, pain, depression and fatigue: open-loop neurofeedback Audio Visual Stimulation (AVS). AVS uses preprogrammed light and sound patterns to evoke brainwave potentials at pre-set designated frequencies. The AVS intervention consists of 30 minutes of light and sound pulsing stimuli that gradually descend from alpha (10 Hz) to delta (2 Hz) frequencies. AVS placebo consists of 30 minutes of constant dim light slowly changing in color, and a steady monotone at ultra-low frequency (below 1 Hz). This proposed study builds upon our successful completion of three pilot studies using AVS. Based on the pilot findings, we hypothesize that the use of active AVS at bedtime induces delta brainwaves, but additional testing is needed to determine how long AVS should be used to produce significant improvements in subjective sleep quality relative to placebo control. In addition, we propose to experimentally test the effect of blue light, which is known to suppress melatonin production, as a potential confounding variable in the AVS intervention. We propose a trial of AVS in 75 community dwelling older adults with chronic comorbid insomnia and OA pain. After baseline assessment, participants will be randomized to 3 groups: AVS-1 (red, green \& blue light) vs. AVS-2 (red \& green light only) vs. placebo AVS. Participants will self-administer AVS at bedtime nightly for one month. QEEG will be measured at baseline, and then at 2, 3 and 4 weeks to evaluate neurological responses to AVS over time. Insomnia severity will be similarly assessed to determine the most efficacious AVS treatment duration and color array for improving insomnia symptoms. OA-related symptoms (pain, depression, and fatigue) and objective sleep outcomes will also be assessed. Data will inform a definitive RCT of AVS for insomnia and relative OA symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active AVS-1 | Experimental | Device: Audiovisual StimulationActive AVS-1 consists of a 30-minute pulsing lights (red, green, blue) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz). |
| Active AVS-2 | Experimental | Device: Audiovisual StimulationActive AVS-2 consists of a 30-minute pulsing lights (red, green) and sounds that gradually descend from alpha (10 Hz) to delta (2 Hz). |
| Placebo AVS | Placebo comparator | Device: Audiovisual StimulationThe 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). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual StimulationA commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study. | Device | Active AVS-1, Active AVS-2, Placebo AVS |
Primary outcome
Insomnia of Severity Index
Time frame: Baseline through 4 weeks post baseline
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.
Quantitative Electroencephalogram (QEEG)
Time frame: Baseline through 4 weeks post baseline
Cortical activity will be evaluated using a 19-channel quantitative electroencephalographic system (Discovery 24E, BrainMaster) with a standard electrode cap that has 22 sensors attaching to the scalp.
7 secondary outcomes
Actigraphy
Time frame: Baseline through 4 weeks post baseline
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Baseline through 4 weeks post baseline
Brief Pain Inventory (BPI) short form
Time frame: Baseline through 4 weeks post baseline
Patient Health Questionnaire
Time frame: Baseline through 4 weeks post baseline
Sleep Diary
Time frame: Baseline through 4 weeks post baseline
Flinders Fatigue Scale
Time frame: A 7-item self-report questionnaire to measure fatigue level in a variety of situations. It has strong internal reliability and validity, and been used to measure fatigue with older adults
General Anxiety Disorder-7
Time frame: Baseline through 4 weeks post baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2022.
- Results publication: PubMed 25931250Tang 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.
- Results publication: PubMed 25257144Tang 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.
- Results publication: PubMed 26294268Tang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Tang, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
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 at 1 site in United States.
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 7 inclusion and 19 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 20 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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: Baseline through 4 weeks post baseline). The study lists 2 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 NCT03569865, 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 20 Jan 2022.