hBET for Pain and Sleep Feasibility

NCT ID: NCT04176861

Last Updated: 2023-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-20
• Study Completion Date: 2021-12-31

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. 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.

Conditions

Pain, Chronic; Sleep Disturbance

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Home based intervention

Participants using hBET technology at home (all participants).

Group Type: EXPERIMENTAL

home-based Brainwave Entrainment Technology

Intervention Type: DEVICE

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

Interventions

home-based Brainwave Entrainment Technology

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Leeds

OTHER

Sponsor Role: collaborator

University of Manchester

OTHER

Sponsor Role: lead

Responsible Party

Stephen Halpin

Visiting Clinical Research Fellow

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Manchester

Manchester, England, United Kingdom

Countries

United Kingdom

References

Halpin SJ, Casson AJ, Tang NKY, Jones AKP, O'Connor RJ, Sivan M. A feasibility study of pre-sleep audio and visual alpha brain entrainment for people with chronic pain and sleep disturbance. Front Pain Res (Lausanne). 2023 Feb 23;4:1096084. doi: 10.3389/fpain.2023.1096084. eCollection 2023.

Reference Type: DERIVED

PMID: 36910250 (View on PubMed)

Other Identifiers

NHS001542

Identifier Type: -

Identifier Source: org_study_id