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Alpha Entrainment for Pain and Sleep (Extension)

Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05699837
Enrollment
19
Registered
2023-01-26
Start date
2022-09-19
Completion date
2024-12-31
Last updated
2025-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Chronic, Sleep Disturbance

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.

Interventions

DEVICEAudio or visual alpha (10Hz) stimulation

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

Sponsors

University of Leeds
CollaboratorOTHER
University of Warwick
CollaboratorOTHER
University of Manchester
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Masking description

The stimulation is delivered via a smartphone application. Each participant will receive one of two versions, which are identical apart from the order in which the two types of stimulation are given. The participant and the investigator enrolling participants and conducting questionnaire and interview outcome assessment, will be masked as to which version they are using. The record of which version was allocated to which participant will be held centrally by co-investigators with no direct participant contact, until results are analysed.

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in alpha power from baselineDaily for 6 weeksAlpha 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 IndexWeeks 1, 3 and 6Sleep 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

MeasureTime frameDescription
DREEM headband; total sleep timeDaily for 6 weeksTotal sleep time (minutes)
Actigraphy; total sleep timeDaily for 6 weeksTotal sleep time (minutes)
Daily sleep diary; sleep onset latencyDaily for 6 weeksSleep onset latency (minutes)
DREEM headband; sleep onset latencyDaily for 6 weeksSleep onset latency (minutes)
Actigraphy; sleep onset latencyDaily for 6 weeksSleep onset latency (minutes)
Daily sleep diary; Wake after sleep onsetDaily for 6 weeksWake after sleep onset (minutes)
DREEM Headband; Wake after sleep onsetDaily for 6 weeksWake after sleep onset (minutes)
Actigraphy; Wake after sleep onsetDaily for 6 weeksWake after sleep onset (minutes)
Daily sleep diary; Sleep EfficiencyDaily for 6 weekssleep efficiency (%)
DREEM headband; Sleep EfficiencyDaily for 6 weekssleep efficiency (%)
Daily pain diaryDaily for 6 weekspain over 24 hours and at night (0-10 NRS)
Daily sleep diary; Sleep qualityDaily for 6 weeksRating of quality (0-5 NRS) and refreshed (0-5 NRS)
DREEM headband derived sleep architectureDaily for 6 weeksDuration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
DREEM headband derived microarousal indexDaily for 6 weeksMicroarousal frequency (events/hour)
DREEM headband recorded awakeningsDaily for 6 weeksAwakenings (number)
Brief Pain Inventory Pain Interference scoreWeekly for 6 weeks0-10 NRS for pain interference
Brief Pain Inventory Severity scoreWeekly for 6 weeks0-10 NRS for pain severity
Hospital Anxiety and Depression ScaleWeeks 1, 3 and 6Scores of 0-21 for anxiety, 0-21 for depression
Multidimensional Fatigue InventoryWeeks 1, 3 and 6Score of 20-100
EuroQol 5 Dimensions (EQ-5D-5L)Weeks 1, 3 and 60-1 global index score, 0-100 VAS score.
Actigraphy; Sleep EfficiencyDaily for 6 weekssleep efficiency (%)
Daily sleep diary; total sleep timeDaily for 6 weeksTotal sleep time (minutes)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026