Clinical trial NCT04176861: hBET for Pain and Sleep Feasibility
Official title: Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: A Feasibility Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Sleep Disturbance
Keywords: audio-visual stimulation
brainwave entrainment
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: University of Leeds
First posted: 2019-11-25
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Qualitative semi-structured interviews
timeFrame: 5 weeks
Secondary outcomes:
measure: Sleep and pain diary
timeFrame: 5 weeks
measure: Actigraphy
timeFrame: 5 weeks
measure: Brief Pain Inventory
timeFrame: 5 weeks
measure: Pittsburgh Sleep Quality Index
timeFrame: 5 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: 5 weeks
measure: Multidimensional Fatigue Inventory
timeFrame: 5 weeks
measure: EuroQol 5 Dimensions (EQ-5D-5L)
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: England
Study officials:
References: