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NCT Number: NCT04176861

hBET for Pain and Sleep Feasibility

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. The next step is to find out whether these tools can be reliably used in home settings, how people feel about using this approach, and to gather information to design a larger trial of this technology.

Therefore the aim of this study is to test the suitability and acceptability of these home-based tools with individuals with long-term pain. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for at least 20 minutes at bed time every day for 4 weeks. The investigators will interview them to ask about their experiences of using the tools, and their feedback and suggestions on how the approach should be developed. The investigators will measure changes in the nature of participants' pain, sleep, fatigue and mood.

These findings will inform the planning and design of a future much larger study to test this technology. The investigators will make sure that findings from this study are shared widely within the National Health Service and beyond among patient groups, professionals, charities, specialist centres and commissioners.

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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, M13 9PL, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic non-cancer pain (recurring pain ≥ 3 months duration)
  • 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 (injection/ surgery/ new oral medications for pain or sleep) during the 4-week hBET use 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

Treatment and study plan

home-based Brainwave Entrainment Technology

Device

Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights

Primary outcomes

  1. Qualitative semi-structured interviews

    Time frame: 5 weeks

    Interview at end of intervention period, following an interview guide, with responses thematically analysed

Secondary outcomes

  1. Sleep and pain diary

    Time frame: 5 weeks

    Bespoke daily diary recording self reported pain and sleep

  2. Actigraphy

    Time frame: 5 weeks

    Motion watch-based objective measure of gross sleep temporal parameters (total sleep time, sleep latency, wakenings after sleep onset, sleep efficiency)

  3. Brief Pain Inventory

    Time frame: 5 weeks

    Gives two scores of 0-10 for pain severity and pain interference respectively, with 10 being worst in both cases.

  4. Pittsburgh Sleep Quality Index

    Time frame: 5 weeks

    Gives a score of 0-21 with higher score indicating worse sleep quality

  5. Hospital Anxiety and Depression Scale

    Time frame: 5 weeks

    Gives two scores of 0-21 for depression and anxiety respectively, with 21 being worst in both cases

  6. Multidimensional Fatigue Inventory

    Time frame: 5 weeks

    Gives a score of 20-100, with higher scores indicating a higher level of fatigue

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

    Time frame: 5 weeks

    A measure of global health state, providing a score of 1-5 in each of 5 domains (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), a global index score derived from population references ranging from 0-1 and a self reported description of overall health status on a 0-100 visual-analogue scale

Sponsors and collaborators

Lead sponsor

University of Manchester

Other

Collaborators

  • University of Leeds

Registry information

Official study title

Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: A Feasibility Study.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 25, 2019
Registry last updated
May 17, 2023

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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