Pain, ChronicNCT05699837
Alpha Entrainment for Pain and Sleep (Extension)
A study testing Audio or visual alpha (10Hz) stimulation in people with Pain, Chronic and Sleep Disturbance, run by University of Manchester at 2 sites in United Kingdom.
Trial summary
Long-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pain, Chronic, Sleep Disturbance
- What is being tested?
- Audio or visual alpha (10Hz) stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 19 Sep 2022to 31 Dec 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80 years
- Chronic non-cancer pain (recurring pain ≥ 3 months duration)
- Diagnosis of fibromyalgia, meeting 2016 ACR criteria.
- Having nocturnal pain (NRS 0-10 worst pain ≥ 4)
- Self-reported sleep difficulties (trouble falling asleep, difficulty staying asleep, waking up too early, or waking up unrefreshed) 3 or more nights per week during the past month
Who cannot join
- Planned intervention during the study period
- Seizure disorder
- Photosensitivity
- Hearing or sight problems causing inability to use hBET
- Cognitive problems or dementia or mental health disorders causing inability to consent
- Night shift worker
- Any known primary sleep disorder including obstructive sleep apnoea, narcolepsy, restless leg syndrome
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Leeds Community Healthcare NHS Trust
Leeds
University of Manchester
Manchester, England, M13 9PL
About this study
Official title: Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study
Long-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term pain is also very costly to the National Health Service. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects for some patients.
The investigators have been developing an alternative approach for treating long-term pain. This approach uses simple non-invasive tools to promote some kinds of brain activity over others. It involves patients using headphones to listen to some specific sounds, or a headset with lights flashing at particular frequencies. The studies undertaken so far seem to show that doing this can change how the brain responds to pain. It potentially offers an inexpensive yet effective way of reducing pain and improving sleep for patients with long-term pain. There are a few small studies that support this approach and more work is needed. In a recent study the investigators found that these tools can be reliably used in home settings and there were some indications that they improved symptoms. However, sleep was only measured with sleep diary and movement detection, there was no direct measurement of whether the stimulation frequencies were resulting in the desired brainwave changes. Finally, the benefit to symptoms may have been the result of other factors, such as the passage of time or placebo effect.
Read more
Therefore this study extends the experiment, adding more accurate sleep monitoring which includes monitoring electrical activity in the brain (EEG), as well as providing rhythmic and non-rhythmic stimulation in a randomised order. The aim is to further test the effect of these home-based tools with individuals with long-term pain, in a more rigorous way. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for 30 minutes at bed time every day for 4 weeks (2 weeks with one type of stimulation, 2 weeks with another type). The changes in participants' pain, sleep, brainwave frequencies, fatigue and mood will be measured.
These findings will inform the planning and design of a future much larger study to test this technology, if this is justified by the results.
- Conditions
- Pain, Chronic, Sleep Disturbance
- Being tested
- Audio or visual alpha (10Hz) stimulation
- Medical subject headings
- Chronic Pain, Parasomnias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio or visual alpha (10Hz) stimulationDevice
Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights, to deliver rhythmic 10Hz or non-rhythmic stimulation
| Study group | Role | What they receive |
|---|---|---|
| hBET 1 | Experimental | Rhythmic stimulation (2 weeks) followed by non-rhythmic stimulation (2 weeks) Receives: Device: Audio or visual alpha (10Hz) stimulation |
| hBET 2 | Experimental | Non-rhythmic stimulation (2 weeks) followed by rhythmic stimulation (2 weeks) Receives: Device: Audio or visual alpha (10Hz) stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alpha power from baseline
Alpha spectral power in active stimulation use periods compared to sham stimulation use periods relative to equivalent baseline periods.
Measured: Daily for 6 weeks
Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index
Sleep quality (0-21 score) at the end of 2 week active stimulation use period compared to at the end of 2 week sham stimulation use period each relative to the baseline period.
Measured: Weeks 1, 3 and 6
Secondary outcomes (22)
Daily pain diary
pain over 24 hours and at night (0-10 NRS)
Measured: Daily for 6 weeks
Daily sleep diary; total sleep time
Total sleep time (minutes)
Measured: Daily for 6 weeks
DREEM headband; total sleep time
Total sleep time (minutes)
Measured: Daily for 6 weeks
Actigraphy; total sleep time
Total sleep time (minutes)
Measured: Daily for 6 weeks
Daily sleep diary; sleep onset latency
Sleep onset latency (minutes)
Measured: Daily for 6 weeks
DREEM headband; sleep onset latency
Sleep onset latency (minutes)
Measured: Daily for 6 weeks
Actigraphy; sleep onset latency
Sleep onset latency (minutes)
Measured: Daily for 6 weeks
Daily sleep diary; Wake after sleep onset
Wake after sleep onset (minutes)
Measured: Daily for 6 weeks
DREEM Headband; Wake after sleep onset
Wake after sleep onset (minutes)
Measured: Daily for 6 weeks
Actigraphy; Wake after sleep onset
Wake after sleep onset (minutes)
Measured: Daily for 6 weeks
Daily sleep diary; Sleep Efficiency
sleep efficiency (%)
Measured: Daily for 6 weeks
DREEM headband; Sleep Efficiency
sleep efficiency (%)
Measured: Daily for 6 weeks
Actigraphy; Sleep Efficiency
sleep efficiency (%)
Measured: Daily for 6 weeks
Daily sleep diary; Sleep quality
Rating of quality (0-5 NRS) and refreshed (0-5 NRS)
Measured: Daily for 6 weeks
DREEM headband derived sleep architecture
Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
Measured: Daily for 6 weeks
DREEM headband derived microarousal index
Microarousal frequency (events/hour)
Measured: Daily for 6 weeks
DREEM headband recorded awakenings
Awakenings (number)
Measured: Daily for 6 weeks
Brief Pain Inventory Pain Interference score
0-10 NRS for pain interference
Measured: Weekly for 6 weeks
Brief Pain Inventory Severity score
0-10 NRS for pain severity
Measured: Weekly for 6 weeks
Hospital Anxiety and Depression Scale
Scores of 0-21 for anxiety, 0-21 for depression
Measured: Weeks 1, 3 and 6
Multidimensional Fatigue Inventory
Score of 20-100
Measured: Weeks 1, 3 and 6
EuroQol 5 Dimensions (EQ-5D-5L)
0-1 global index score, 0-100 VAS score.
Measured: Weeks 1, 3 and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2023
- Study start19 Sep 2022
- Primary completion31 Dec 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe 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
- Crossover
- Model description
- Following a baseline period each participant will use two types of sensory stimulation for two weeks, in a randomised order, with a 1 week washout period.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds, University of Warwick
- Responsible party
- Principal investigator, Stephen Halpin, University of Manchester
- Investigators
- Anthony KP Jones, Study director, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05699837
- Sponsor's protocol ID
- NHS001542(2)
- Status last verified
- Jan 2025
- First submitted
- 22 Nov 2022
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study
- ClinicalTrials.gov ID
- NCT05699837
- Acronym / sponsor ID
- NHS001542(2)
- Conditions
- Pain, Chronic, Sleep Disturbance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds, University of Warwick
- Study start
- 19 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 26 Jan 2023 (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.
Long-term pain affects one-third of the United Kingdom population and can be very disabling. People experiencing long-term pain often suffer from disturbed sleep because of their pain symptoms, and disturbed sleep can then make their pain symptoms worse. Managing long-term pain is also very costly to the National Health Service. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects for some patients.
The investigators have been developing an alternative approach for treating long-term pain. This approach uses simple non-invasive tools to promote some kinds of brain activity over others. It involves patients using headphones to listen to some specific sounds, or a headset with lights flashing at particular frequencies. The studies undertaken so far seem to show that doing this can change how the brain responds to pain. It potentially offers an inexpensive yet effective way of reducing pain and improving sleep for patients with long-term pain. There are a few small studies that support this approach and more work is needed. In a recent study the investigators found that these tools can be reliably used in home settings and there were some indications that they improved symptoms. However, sleep was only measured with sleep diary and movement detection, there was no direct measurement of whether the stimulation frequencies were resulting in the desired brainwave changes. Finally, the benefit to symptoms may have been the result of other factors, such as the passage of time or placebo effect.
Therefore this study extends the experiment, adding more accurate sleep monitoring which includes monitoring electrical activity in the brain (EEG), as well as providing rhythmic and non-rhythmic stimulation in a randomised order. The aim is to further test the effect of these home-based tools with individuals with long-term pain, in a more rigorous way. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for 30 minutes at bed time every day for 4 weeks (2 weeks with one type of stimulation, 2 weeks with another type). The changes in participants' pain, sleep, brainwave frequencies, fatigue and mood will be measured.
These findings will inform the planning and design of a future much larger study to test this technology, if this is justified by the results.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Following a baseline period each participant will use two types of sensory stimulation for two weeks, in a randomised order, with a 1 week washout period.
| Arm | Type | Receives |
|---|---|---|
| hBET 1 | Experimental | Device: Audio or visual alpha (10Hz) stimulationRhythmic stimulation (2 weeks) followed by non-rhythmic stimulation (2 weeks) |
| hBET 2 | Experimental | Device: Audio or visual alpha (10Hz) stimulationNon-rhythmic stimulation (2 weeks) followed by rhythmic stimulation (2 weeks) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-80 years
- Chronic non-cancer pain (recurring pain ≥ 3 months duration)
- Diagnosis of fibromyalgia, meeting 2016 ACR criteria.
- Having nocturnal pain (NRS 0-10 worst pain ≥ 4)
- Self-reported sleep difficulties (trouble falling asleep, difficulty staying asleep, waking up too early, or waking up unrefreshed) 3 or more nights per week during the past month
Key exclusion criteria (7 listed)
- Planned intervention during the study period
- Seizure disorder
- Photosensitivity
- Hearing or sight problems causing inability to use hBET
- Cognitive problems or dementia or mental health disorders causing inability to consent
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 |
|---|---|---|
| Audio or visual alpha (10Hz) stimulationSmartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights, to deliver rhythmic 10Hz or non-rhythmic stimulation | Device | hBET 1, hBET 2 |
Primary outcome
Change in alpha power from baseline
Time frame: Daily for 6 weeks
Alpha spectral power in active stimulation use periods compared to sham stimulation use periods relative to equivalent baseline periods.
Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index
Time frame: Weeks 1, 3 and 6
Sleep quality (0-21 score) at the end of 2 week active stimulation use period compared to at the end of 2 week sham stimulation use period each relative to the baseline period.
22 secondary outcomes
Daily pain diary
Time frame: Daily for 6 weeks
Daily sleep diary; total sleep time
Time frame: Daily for 6 weeks
DREEM headband; total sleep time
Time frame: Daily for 6 weeks
Actigraphy; total sleep time
Time frame: Daily for 6 weeks
Daily sleep diary; sleep onset latency
Time frame: Daily for 6 weeks
DREEM headband; sleep onset latency
Time frame: Daily for 6 weeks
Actigraphy; sleep onset latency
Time frame: Daily for 6 weeks
Daily sleep diary; Wake after sleep onset
Time frame: Daily for 6 weeks
DREEM Headband; Wake after sleep onset
Time frame: Daily for 6 weeks
Actigraphy; Wake after sleep onset
Time frame: Daily for 6 weeks
Daily sleep diary; Sleep Efficiency
Time frame: Daily for 6 weeks
DREEM headband; Sleep Efficiency
Time frame: Daily for 6 weeks
Actigraphy; Sleep Efficiency
Time frame: Daily for 6 weeks
Daily sleep diary; Sleep quality
Time frame: Daily for 6 weeks
DREEM headband derived sleep architecture
Time frame: Daily for 6 weeks
DREEM headband derived microarousal index
Time frame: Daily for 6 weeks
DREEM headband recorded awakenings
Time frame: Daily for 6 weeks
Brief Pain Inventory Pain Interference score
Time frame: Weekly for 6 weeks
Brief Pain Inventory Severity score
Time frame: Weekly for 6 weeks
Hospital Anxiety and Depression Scale
Time frame: Weeks 1, 3 and 6
Multidimensional Fatigue Inventory
Time frame: Weeks 1, 3 and 6
EuroQol 5 Dimensions (EQ-5D-5L)
Time frame: Weeks 1, 3 and 6
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 15 Jan 2025.
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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.
Anthony KP Jones study director
University of Manchester
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Audio or visual alpha (10Hz) stimulation in people with Pain, Chronic and Sleep Disturbance, run by University of Manchester at 2 sites in United Kingdom.
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 5 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 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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. 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?
Change in alpha power from baseline (time frame: Daily for 6 weeks). 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?
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 15 Jan 2025.