hBET for Pain and Sleep Feasibility

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Disturbance; Pain, Chronic
• Intervention / Treatment: Device: home-based Brainwave Entrainment Technology

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • England
    • Manchester, England, United Kingdom, M13 9PL
      • University of Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home based intervention; Participants using hBET technology at home (all participants).	Device: home-based Brainwave Entrainment Technology; Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative semi-structured interviews	Interview at end of intervention period, following an interview guide, with responses thematically analysed	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sleep and pain diary	Bespoke daily diary recording self reported pain and sleep	5 weeks
Actigraphy	Motion watch-based objective measure of gross sleep temporal parameters (total sleep time, sleep latency, wakenings after sleep onset, sleep efficiency)	5 weeks
Brief Pain Inventory	Gives two scores of 0-10 for pain severity and pain interference respectively, with 10 being worst in both cases.	5 weeks
Pittsburgh Sleep Quality Index	Gives a score of 0-21 with higher score indicating worse sleep quality	5 weeks
Hospital Anxiety and Depression Scale	Gives two scores of 0-21 for depression and anxiety respectively, with 21 being worst in both cases	5 weeks
Multidimensional Fatigue Inventory	Gives a score of 20-100, with higher scores indicating a higher level of fatigue	5 weeks
EuroQol 5 Dimensions (EQ-5D-5L)	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	5 weeks

Collaborators and Investigators

• Sponsor: University of Manchester
• Collaborators: University of Leeds

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 18, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: audio-visual stimulation; brainwave entrainment
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Wake Disorders; Pain; Neurologic Manifestations; Chronic Pain; Dyssomnias; Parasomnias
• Other Study ID Numbers: NHS001542

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No