Audio or visual alpha (10Hz) stimulation
DeviceSmartphone 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
NCT Number: NCT05699837
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
University of Manchester, Manchester, England, United Kingdom
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
Time frame: Daily for 6 weeks
pain over 24 hours and at night (0-10 NRS)
Time frame: Daily for 6 weeks
Total sleep time (minutes)
Time frame: Daily for 6 weeks
Total sleep time (minutes)
Time frame: Daily for 6 weeks
Total sleep time (minutes)
Time frame: Daily for 6 weeks
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
Sleep onset latency (minutes)
Time frame: Daily for 6 weeks
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
Wake after sleep onset (minutes)
Time frame: Daily for 6 weeks
sleep efficiency (%)
Time frame: Daily for 6 weeks
sleep efficiency (%)
Time frame: Daily for 6 weeks
sleep efficiency (%)
Time frame: Daily for 6 weeks
Rating of quality (0-5 NRS) and refreshed (0-5 NRS)
Time frame: Daily for 6 weeks
Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
Time frame: Daily for 6 weeks
Microarousal frequency (events/hour)
Time frame: Daily for 6 weeks
Awakenings (number)
Time frame: Weekly for 6 weeks
0-10 NRS for pain interference
Time frame: Weekly for 6 weeks
0-10 NRS for pain severity
Time frame: Weeks 1, 3 and 6
Scores of 0-21 for anxiety, 0-21 for depression
Time frame: Weeks 1, 3 and 6
Score of 20-100
Time frame: Weeks 1, 3 and 6
0-1 global index score, 0-100 VAS score.
University of Manchester
Other
Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study
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