hBET for Pain and Sleep Feasibility

NCT04176861 | Completed

• 1 other identifier: NHS001542
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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

Keywords

audio-visual stimulation; brainwave entrainment

Outcome Measures

Primary Outcomes (1)

• Qualitative semi-structured interviews

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

  5 weeks

Secondary Outcomes (7)

• Sleep and pain diary

  5 weeks

• Actigraphy

  5 weeks

• Brief Pain Inventory

  5 weeks

• Pittsburgh Sleep Quality Index

  5 weeks

• Hospital Anxiety and Depression Scale

  5 weeks

Study Arms (1)

Home based intervention

EXPERIMENTAL

Participants using hBET technology at home (all participants).

Device: home-based Brainwave Entrainment Technology

Interventions

home-based Brainwave Entrainment Technology DEVICE

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

Home based intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manchester: lead
• University of Leeds: collaborator

Study Sites (1)

University of Manchester

Manchester, England, M13 9PL, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 36910250 DERIVED

MeSH Terms

Conditions

Chronic Pain; Parasomnias

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Visiting Clinical Research Fellow

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: November 25, 2019
• Study Start: January 20, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)