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Completed

NCT Number: NCT05699837

Alpha Entrainment for Pain and Sleep (Extension)

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Manchester, Manchester, England, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Audio or visual alpha (10Hz) stimulation

Device

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

Primary outcomes

  1. Change in alpha power from baseline

    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.

  2. Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index

    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.

Secondary outcomes

  1. Daily pain diary

    Time frame: Daily for 6 weeks

    pain over 24 hours and at night (0-10 NRS)

  2. Daily sleep diary; total sleep time

    Time frame: Daily for 6 weeks

    Total sleep time (minutes)

  3. DREEM headband; total sleep time

    Time frame: Daily for 6 weeks

    Total sleep time (minutes)

  4. Actigraphy; total sleep time

    Time frame: Daily for 6 weeks

    Total sleep time (minutes)

  5. Daily sleep diary; sleep onset latency

    Time frame: Daily for 6 weeks

    Sleep onset latency (minutes)

  6. DREEM headband; sleep onset latency

    Time frame: Daily for 6 weeks

    Sleep onset latency (minutes)

  7. Actigraphy; sleep onset latency

    Time frame: Daily for 6 weeks

    Sleep onset latency (minutes)

  8. Daily sleep diary; Wake after sleep onset

    Time frame: Daily for 6 weeks

    Wake after sleep onset (minutes)

  9. DREEM Headband; Wake after sleep onset

    Time frame: Daily for 6 weeks

    Wake after sleep onset (minutes)

  10. Actigraphy; Wake after sleep onset

    Time frame: Daily for 6 weeks

    Wake after sleep onset (minutes)

  11. Daily sleep diary; Sleep Efficiency

    Time frame: Daily for 6 weeks

    sleep efficiency (%)

  12. DREEM headband; Sleep Efficiency

    Time frame: Daily for 6 weeks

    sleep efficiency (%)

  13. Actigraphy; Sleep Efficiency

    Time frame: Daily for 6 weeks

    sleep efficiency (%)

  14. Daily sleep diary; Sleep quality

    Time frame: Daily for 6 weeks

    Rating of quality (0-5 NRS) and refreshed (0-5 NRS)

  15. DREEM headband derived sleep architecture

    Time frame: Daily for 6 weeks

    Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)

  16. DREEM headband derived microarousal index

    Time frame: Daily for 6 weeks

    Microarousal frequency (events/hour)

  17. DREEM headband recorded awakenings

    Time frame: Daily for 6 weeks

    Awakenings (number)

  18. Brief Pain Inventory Pain Interference score

    Time frame: Weekly for 6 weeks

    0-10 NRS for pain interference

  19. Brief Pain Inventory Severity score

    Time frame: Weekly for 6 weeks

    0-10 NRS for pain severity

  20. Hospital Anxiety and Depression Scale

    Time frame: Weeks 1, 3 and 6

    Scores of 0-21 for anxiety, 0-21 for depression

  21. Multidimensional Fatigue Inventory

    Time frame: Weeks 1, 3 and 6

    Score of 20-100

  22. EuroQol 5 Dimensions (EQ-5D-5L)

    Time frame: Weeks 1, 3 and 6

    0-1 global index score, 0-100 VAS score.

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • University of Leeds
  • University of Warwick

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 26, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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