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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
19
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
University of Manchester
Manchester, England, United Kingdom
Leeds Community Healthcare NHS Trust
Leeds, United Kingdom
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.
Time frame: 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.
Time frame: Weeks 1, 3 and 6
Daily pain diary
pain over 24 hours and at night (0-10 NRS)
Time frame: Daily for 6 weeks
Daily sleep diary; total sleep time
Total sleep time (minutes)
Time frame: Daily for 6 weeks
DREEM headband; total sleep time
Total sleep time (minutes)
Time frame: Daily for 6 weeks
Actigraphy; total sleep time
Total sleep time (minutes)
Time frame: Daily for 6 weeks
Daily sleep diary; sleep onset latency
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
DREEM headband; sleep onset latency
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
Actigraphy; sleep onset latency
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
Daily sleep diary; Wake after sleep onset
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
DREEM Headband; Wake after sleep onset
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
Actigraphy; Wake after sleep onset
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
Daily sleep diary; Sleep Efficiency
sleep efficiency (%)
Time frame: Daily for 6 weeks
DREEM headband; Sleep Efficiency
sleep efficiency (%)
Time frame: Daily for 6 weeks
Actigraphy; Sleep Efficiency
sleep efficiency (%)
Time frame: Daily for 6 weeks
Daily sleep diary; Sleep quality
Rating of quality (0-5 NRS) and refreshed (0-5 NRS)
Time frame: Daily for 6 weeks
DREEM headband derived sleep architecture
Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
Time frame: Daily for 6 weeks
DREEM headband derived microarousal index
Microarousal frequency (events/hour)
Time frame: Daily for 6 weeks
DREEM headband recorded awakenings
Awakenings (number)
Time frame: Daily for 6 weeks
Brief Pain Inventory Pain Interference score
0-10 NRS for pain interference
Time frame: Weekly for 6 weeks
Brief Pain Inventory Severity score
0-10 NRS for pain severity
Time frame: Weekly for 6 weeks
Hospital Anxiety and Depression Scale
Scores of 0-21 for anxiety, 0-21 for depression
Time frame: Weeks 1, 3 and 6
Multidimensional Fatigue Inventory
Score of 20-100
Time frame: Weeks 1, 3 and 6
EuroQol 5 Dimensions (EQ-5D-5L)
0-1 global index score, 0-100 VAS score.
Time frame: Weeks 1, 3 and 6
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