Alpha Entrainment for Pain and Sleep (Extension)
- Conditions
- Pain, ChronicSleep Disturbance
- Interventions
- Device: Audio or visual alpha (10Hz) stimulation
- Registration Number
- NCT05699837
- Lead Sponsor
- University of Manchester
- 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. 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description hBET 1 Audio or visual alpha (10Hz) stimulation Rhythmic stimulation (2 weeks) followed by non-rhythmic stimulation (2 weeks) hBET 2 Audio or visual alpha (10Hz) stimulation Non-rhythmic stimulation (2 weeks) followed by rhythmic stimulation (2 weeks)
- Primary Outcome Measures
Name Time Method Change in alpha power from baseline Daily for 6 weeks Alpha spectral power in active stimulation use periods compared to sham stimulation use periods relative to equivalent baseline periods.
Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index 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.
- Secondary Outcome Measures
Name Time Method Actigraphy; total sleep time Daily for 6 weeks Total sleep time (minutes)
DREEM headband; sleep onset latency Daily for 6 weeks Sleep onset latency (minutes)
Daily sleep diary; Wake after sleep onset Daily for 6 weeks Wake after sleep onset (minutes)
Daily sleep diary; Sleep Efficiency Daily for 6 weeks sleep efficiency (%)
Daily sleep diary; Sleep quality Daily for 6 weeks Rating of quality (0-5 NRS) and refreshed (0-5 NRS)
DREEM headband derived microarousal index Daily for 6 weeks Microarousal frequency (events/hour)
Actigraphy; Wake after sleep onset Daily for 6 weeks Wake after sleep onset (minutes)
DREEM headband; Sleep Efficiency Daily for 6 weeks sleep efficiency (%)
Actigraphy; Sleep Efficiency Daily for 6 weeks sleep efficiency (%)
Brief Pain Inventory Pain Interference score Weekly for 6 weeks 0-10 NRS for pain interference
Daily pain diary Daily for 6 weeks pain over 24 hours and at night (0-10 NRS)
Daily sleep diary; total sleep time Daily for 6 weeks Total sleep time (minutes)
DREEM headband; total sleep time Daily for 6 weeks Total sleep time (minutes)
Actigraphy; sleep onset latency Daily for 6 weeks Sleep onset latency (minutes)
Brief Pain Inventory Severity score Weekly for 6 weeks 0-10 NRS for pain severity
Multidimensional Fatigue Inventory Weeks 1, 3 and 6 Score of 20-100
Daily sleep diary; sleep onset latency Daily for 6 weeks Sleep onset latency (minutes)
DREEM Headband; Wake after sleep onset Daily for 6 weeks Wake after sleep onset (minutes)
DREEM headband derived sleep architecture Daily for 6 weeks Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
DREEM headband recorded awakenings Daily for 6 weeks Awakenings (number)
Hospital Anxiety and Depression Scale Weeks 1, 3 and 6 Scores of 0-21 for anxiety, 0-21 for depression
EuroQol 5 Dimensions (EQ-5D-5L) Weeks 1, 3 and 6 0-1 global index score, 0-100 VAS score.
Trial Locations
- Locations (2)
University of Manchester
🇬🇧Manchester, England, United Kingdom
Leeds Community Healthcare NHS Trust
🇬🇧Leeds, United Kingdom