hBET for Pain and Sleep feasibility v1.0
Research type
Research Study
Full title
Home-based Brainwave Entrainment Technology (hBET) for management of chronic pain and sleep disturbance. A feasibility study.
IRAS ID
261462
Contact name
Anthony Jones
Contact email
Sponsor organisation
University of Manchester
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Research 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 very costly to the NHS. The most common treatment is prescribed medicines, but these do not always work and can have serious side-effects.
We have been developing an alternative approach for treating long-term pain. Our approach uses very simple non-invasive tools to promote some kinds of brain activity (called brainwave entrainment). It involves participants using headphones to listen to some specific sounds, or using googles to look at some flashing lights. The studies we have 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. We also want to find out whether our tools can be reliably used in home settings, and whether patients would be happy using our approach.
The aim of this study is to test the suitability and acceptability of our home-based tools with individuals with long-term pain. 30 adult participants with long-term pain and pain-related sleep disturbance will be recruited. They will use our tools for at least 20 minutes before sleep every day for 4 weeks. We will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how we should develop our approach. We will measure changes in the nature of their pain, sleep, fatigue and mood. These findings will inform the planning and design of a future much bigger study to test out our tools.
Summary of Results:
People who live with chronic pain often also struggle with poor sleep, and these two problems can make each other worse. There is some evidence that certain types of sound or light stimulation—set at a specific rhythm of 10 beats per second (called alpha frequency)—can gently influence brain activity and may help reduce pain.
Researchers created a smartphone program that delivers this 10 Hz stimulation using either flickering light or special audio tones (binaural beats). The idea was for people to use it for 30 minutes before bed, to see if it could help improve their sleep and nighttime pain, and in turn improve how they feel during the day.
This early study looked at whether people with chronic pain and sleep problems could use the program as instructed, and whether it showed any signs of benefit.
What the study did:
Participants used the audio or visual stimulation each night for four weeks, after one week of baseline measurements. There was no control group.
Who took part:
28 people completed the study (most were women, average age 45). They used the program regularly and filled in most of the daily questionnaires.
What the study found:
Compared to their baseline week, participants reported:
• Better sleep:
o They slept about 29 minutes longer each night.
o They fell asleep 13 minutes faster.
o Their overall sleep efficiency improved.
• Less nighttime pain:
o Night pain ratings decreased slightly (by 0.5 points on a 0–10 scale).
• Improvements in daily wellbeing:
o Better overall sleep quality.
o Less interference from pain in daily life.
o Reduced fatigue.
o Lower scores on depression and anxiety questionnaires.
What this means:
Using a smartphone-based sound or light stimulation program before bed was practical and acceptable for people with chronic pain and sleep disturbance.A follow-on study was then conducted which added in the use of a sleep headband capable of monitoring brain activity overnight.
The second study built directly on the first by testing the smartphone stimulation in a more rigorous way and focusing on people with fibromyalgia, a condition where chronic widespread pain and poor sleep are especially common.
This time, the researchers focussed in on two things - the Mechanism – Does the stimulation actually increase alpha wave activity in the brain, as intended; and Effectiveness – Does it help with pain and sleep when compared to a “sham” version?
What the study did
Participants completed two separate two week periods:
• Active stimulation: The real rhythmic 10 Hz light or sound.
• Sham stimulation: A similar feeling version, but without the rhythmic timing that causes brain entrainment.
The order was randomised, and neither the participants nor the researchers knew which period was which until the end. There was a one week break between periods.
Participants used the program at home before sleep, and wore an EEG headband each night to measure their brain activity. They also completed daily symptom and sleep diaries.
What the study found
1. Indication that the technique worked as intended in the brain The brain recordings (EEG) showed that during the active stimulation period, participants had stronger alpha wave activity compared to the sham period.
This supports the idea that the smartphone program successfully produces the intended “entrainment” effect even in a home, pre sleep environment.
2. Night time pain improved compared to sham Participants reported lower night time pain during the active stimulation period.
On a 0–10 scale, pain was about half a point lower during active stimulation than during sham.
Although the number may seem small, even modest reductions in pain—especially at night—can be meaningful in chronic conditions like fibromyalgia.
3. Sleep quality improved
Participants rated their sleep quality slightly better during active stimulation than sham.
On a 0–5 scale, sleep quality improved by about 0.4 points.
4. The approach was practical and safe
People were able to use the stimulation and the EEG headband reliably at home, and there were no major unwanted effects.
What this means
This follow on study adds stronger evidence to support the use of pre sleep alpha wave stimulation for chronic pain conditions:
• It supports the idea that stimulation actually changes brain activity in a way that matches the proposed mechanism.
• It shows that these brain changes are linked to improvements in night time pain and sleep quality.
• It demonstrates that people with fibromyalgia can use the system at home without difficulty.
The results are promising, but the study was still relatively small and short. The researchers conclude that larger and longer clinical trials are now justified to confirm the findings and refine the intervention.REC name
Yorkshire & The Humber - Sheffield Research Ethics Committee
REC reference
19/YH/0313
Date of REC Opinion
16 Oct 2019
REC opinion
Further Information Favourable Opinion