Clinical trial NCT05699837: Alpha Entrainment for Pain and Sleep (Extension)
Official title: Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Chronic
Sleep Disturbance
Lead sponsor: University of Manchester
Sponsor class: OTHER
Collaborators: name: University of Leeds
name: University of Warwick
First posted: 2023-01-26
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in alpha power from baseline
timeFrame: Daily for 6 weeks
measure: Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index
timeFrame: Weeks 1, 3 and 6
Secondary outcomes:
measure: Daily pain diary
timeFrame: Daily for 6 weeks
measure: Daily sleep diary; total sleep time
timeFrame: Daily for 6 weeks
measure: DREEM headband; total sleep time
timeFrame: Daily for 6 weeks
measure: Actigraphy; total sleep time
timeFrame: Daily for 6 weeks
measure: Daily sleep diary; sleep onset latency
timeFrame: Daily for 6 weeks
measure: DREEM headband; sleep onset latency
timeFrame: Daily for 6 weeks
measure: Actigraphy; sleep onset latency
timeFrame: Daily for 6 weeks
measure: Daily sleep diary; Wake after sleep onset
timeFrame: Daily for 6 weeks
measure: DREEM Headband; Wake after sleep onset
timeFrame: Daily for 6 weeks
measure: Actigraphy; Wake after sleep onset
timeFrame: Daily for 6 weeks
measure: Daily sleep diary; Sleep Efficiency
timeFrame: Daily for 6 weeks
measure: DREEM headband; Sleep Efficiency
timeFrame: Daily for 6 weeks
measure: Actigraphy; Sleep Efficiency
timeFrame: Daily for 6 weeks
measure: Daily sleep diary; Sleep quality
timeFrame: Daily for 6 weeks
measure: DREEM headband derived sleep architecture
timeFrame: Daily for 6 weeks
measure: DREEM headband derived microarousal index
timeFrame: Daily for 6 weeks
measure: DREEM headband recorded awakenings
timeFrame: Daily for 6 weeks
measure: Brief Pain Inventory Pain Interference score
timeFrame: Weekly for 6 weeks
measure: Brief Pain Inventory Severity score
timeFrame: Weekly for 6 weeks
measure: Hospital Anxiety and Depression Scale
timeFrame: Weeks 1, 3 and 6
measure: Multidimensional Fatigue Inventory
timeFrame: Weeks 1, 3 and 6
measure: EuroQol 5 Dimensions (EQ-5D-5L)
timeFrame: Weeks 1, 3 and 6
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University of Manchester
state: England
city: Leeds
country: United Kingdom
facility: Leeds Community Healthcare NHS Trust
Study officials:
affiliation: University of Manchester
name: Anthony KP Jones
role: STUDY_DIRECTOR
References: