Pain, ChronicNCT04176861
hBET for Pain and Sleep Feasibility
A study testing home-based Brainwave Entrainment Technology in people with Pain, Chronic and Sleep Disturbance, run by University of Manchester at 1 site 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?
- home-based Brainwave Entrainment Technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jan 2020to 31 Dec 2021
- 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
- Chronic non-cancer pain (recurring pain ≥ 3 months duration)
- 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 (injection/ surgery/ new oral medications for pain or sleep) during the 4-week hBET use 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
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: 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. The next step is to find out whether these tools can be reliably used in home settings, how people feel about using this approach, and to gather information to design a larger trial of this technology.
Read more
Therefore the aim of this study is to test the suitability and acceptability of these home-based tools with individuals with long-term pain. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed time every day for 4 weeks. The investigators will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how the approach should be developed. The investigators will measure changes in the nature of participants' pain, sleep, fatigue and mood.
These findings will inform the planning and design of a future much larger study to test this technology. The investigators will make sure that findings from this study are shared widely within the National Health Service and beyond among patient groups, professionals, charities, specialist centres and commissioners.
- Conditions
- Pain, Chronic, Sleep Disturbance
- Being tested
- home-based Brainwave Entrainment Technology
- Keywords
- audio-visual stimulation, brainwave entrainment
- 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.
home-based Brainwave Entrainment TechnologyDevice
Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights
| Study group | Role | What they receive |
|---|---|---|
| Home based intervention | Experimental | Participants using hBET technology at home (all participants). Receives: Device: home-based Brainwave Entrainment Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative semi-structured interviews
Interview at end of intervention period, following an interview guide, with responses thematically analysed
Measured: 5 weeks
Secondary outcomes (7)
Sleep and pain diary
Bespoke daily diary recording self reported pain and sleep
Measured: 5 weeks
Actigraphy
Motion watch-based objective measure of gross sleep temporal parameters (total sleep time, sleep latency, wakenings after sleep onset, sleep efficiency)
Measured: 5 weeks
Brief Pain Inventory
Gives two scores of 0-10 for pain severity and pain interference respectively, with 10 being worst in both cases.
Measured: 5 weeks
Pittsburgh Sleep Quality Index
Gives a score of 0-21 with higher score indicating worse sleep quality
Measured: 5 weeks
Hospital Anxiety and Depression Scale
Gives two scores of 0-21 for depression and anxiety respectively, with 21 being worst in both cases
Measured: 5 weeks
Multidimensional Fatigue Inventory
Gives a score of 20-100, with higher scores indicating a higher level of fatigue
Measured: 5 weeks
EuroQol 5 Dimensions (EQ-5D-5L)
A measure of global health state, providing a score of 1-5 in each of 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), a global index score derived from population references ranging from 0-1 and a self reported description of overall health status on a 0-100 visual-analogue scale
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start20 Jan 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Leeds
- Responsible party
- Principal investigator, Stephen Halpin, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176861
- Sponsor's protocol ID
- NHS001542
- Status last verified
- May 2023
- First submitted
- 18 Nov 2019
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Halpin SJ, Casson AJ, Tang NKY, Jones AKP, O'Connor RJ, Sivan M. A feasibility study of pre-sleep audio and visual alpha brain entrainment for people with chronic pain and sleep disturbance. Front Pain Res (Lausanne). 2023 Feb 23;4:1096084. doi: 10.3389/fpain.2023.1096084. eCollection 2023.
PubMed 36910250
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. 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: A Feasibility Study.
- ClinicalTrials.gov ID
- NCT04176861
- Acronym / sponsor ID
- NHS001542
- Conditions
- Pain, Chronic, Sleep Disturbance
- Keywords
- audio-visual stimulation, brainwave entrainment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- University of Leeds
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 25 Nov 2019 (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. The next step is to find out whether these tools can be reliably used in home settings, how people feel about using this approach, and to gather information to design a larger trial of this technology.
Therefore the aim of this study is to test the suitability and acceptability of these home-based tools with individuals with long-term pain. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed time every day for 4 weeks. The investigators will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how the approach should be developed. The investigators will measure changes in the nature of participants' pain, sleep, fatigue and mood.
These findings will inform the planning and design of a future much larger study to test this technology. The investigators will make sure that findings from this study are shared widely within the National Health Service and beyond among patient groups, professionals, charities, specialist centres and commissioners.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home based intervention | Experimental | Device: home-based Brainwave Entrainment TechnologyParticipants using hBET technology at home (all participants). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic non-cancer pain (recurring pain ≥ 3 months duration)
- 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 (5 listed)
- Planned intervention (injection/ surgery/ new oral medications for pain or sleep) during the 4-week hBET use 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 |
|---|---|---|
| home-based Brainwave Entrainment TechnologySmartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights | Device | Home based intervention |
Primary outcome
Qualitative semi-structured interviews
Time frame: 5 weeks
Interview at end of intervention period, following an interview guide, with responses thematically analysed
7 secondary outcomes
Sleep and pain diary
Time frame: 5 weeks
Actigraphy
Time frame: 5 weeks
Brief Pain Inventory
Time frame: 5 weeks
Pittsburgh Sleep Quality Index
Time frame: 5 weeks
Hospital Anxiety and Depression Scale
Time frame: 5 weeks
Multidimensional Fatigue Inventory
Time frame: 5 weeks
EuroQol 5 Dimensions (EQ-5D-5L)
Time frame: 5 weeks
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 17 May 2023.
- Derived from this study: PubMed 36910250Halpin SJ, Casson AJ, Tang NKY, Jones AKP, O'Connor RJ, Sivan M. A feasibility study of pre-sleep audio and visual alpha brain entrainment for people with chronic pain and sleep disturbance. Front Pain Res (Lausanne). 2023 Feb 23;4:1096084. doi: 10.3389/fpain.2023.1096084. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based Brainwave Entrainment Technology in people with Pain, Chronic and Sleep Disturbance, run by University of Manchester at 1 site 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 3 inclusion and 5 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 17 May 2023. 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 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?
Qualitative semi-structured interviews (time frame: 5 weeks). 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 NCT04176861, which also lists 1 linked publication.
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 17 May 2023.