Alpha Entrainment for Pain and Sleep (Extension)

Study Overview
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Brief Summary
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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.

Official Title
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Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study

Conditions
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Pain, Chronic, Sleep Disturbance

Intervention / Treatment
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* Device: Audio or visual alpha (10Hz) stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hBET 1<br>Rhythmic stimulation (2 weeks) followed by non-rhythmic stimulation (2 weeks) | Device: Audio or visual alpha (10Hz) stimulation<br>* 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<br>|
| Experimental: hBET 2<br>Non-rhythmic stimulation (2 weeks) followed by rhythmic stimulation (2 weeks) | Device: Audio or visual alpha (10Hz) stimulation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Weeks 1, 3 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily pain diary | pain over 24 hours and at night (0-10 NRS) | Daily for 6 weeks | 
| Daily sleep diary; total sleep time | Total sleep time (minutes) | Daily for 6 weeks | 
| DREEM headband; total sleep time | Total sleep time (minutes) | Daily for 6 weeks | 
| Actigraphy; total sleep time | Total sleep time (minutes) | Daily for 6 weeks | 
| Daily sleep diary; sleep onset latency | Sleep onset latency (minutes) | Daily for 6 weeks | 
| DREEM headband; sleep onset latency | Sleep onset latency (minutes) | Daily for 6 weeks | 
| Actigraphy; sleep onset latency | Sleep onset latency (minutes) | Daily for 6 weeks | 
| Daily sleep diary; Wake after sleep onset | Wake after sleep onset (minutes) | Daily for 6 weeks | 
| DREEM Headband; Wake after sleep onset | Wake after sleep onset (minutes) | Daily for 6 weeks | 
| Actigraphy; Wake after sleep onset | Wake after sleep onset (minutes) | Daily for 6 weeks | 
| Daily sleep diary; Sleep Efficiency | sleep efficiency (%) | Daily for 6 weeks | 
| DREEM headband; Sleep Efficiency | sleep efficiency (%) | Daily for 6 weeks | 
| Actigraphy; Sleep Efficiency | sleep efficiency (%) | Daily for 6 weeks | 
| Daily sleep diary; Sleep quality | Rating of quality (0-5 NRS) and refreshed (0-5 NRS) | Daily for 6 weeks | 
| DREEM headband derived sleep architecture | Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM) | Daily for 6 weeks | 
| DREEM headband derived microarousal index | Microarousal frequency (events/hour) | Daily for 6 weeks | 
| DREEM headband recorded awakenings | Awakenings (number) | Daily for 6 weeks | 
| Brief Pain Inventory Pain Interference score | 0-10 NRS for pain interference | Weekly for 6 weeks | 
| Brief Pain Inventory Severity score | 0-10 NRS for pain severity | Weekly for 6 weeks | 
| Hospital Anxiety and Depression Scale | Scores of 0-21 for anxiety, 0-21 for depression | Weeks 1, 3 and 6 | 
| Multidimensional Fatigue Inventory | Score of 20-100 | Weeks 1, 3 and 6 | 
| EuroQol 5 Dimensions (EQ-5D-5L) | 0-1 global index score, 0-100 VAS score. | Weeks 1, 3 and 6 |