hBET for Pain and Sleep Feasibility

Pain, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04176861
• Other study ID #: NHS001542
• Status: Completed
• Phase: N/A
• Start date: January 20, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: May 2023
• Source: University of Manchester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Chronic non-cancer pain (recurring pain = 3 months duration)

• Having nocturnal pain (NRS 0-10 worst pain = 4)

• Self-reported sleep dif?culties (trouble falling asleep, dif?culty 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

Related Conditions & MeSH terms

• Chronic Pain
• Dyssomnias
• Pain, Chronic
• Parasomnias
• Sleep Disturbance

Intervention

Device:
• home-based Brainwave Entrainment Technology
Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights

Locations

Country	Name	City	State
United Kingdom	University of Manchester	Manchester	England

Sponsors (2)

Lead Sponsor	Collaborator
University of Manchester	University of Leeds

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qualitative semi-structured interviews	Interview at end of intervention period, following an interview guide, with responses thematically analysed	5 weeks
Secondary	Sleep and pain diary	Bespoke daily diary recording self reported pain and sleep	5 weeks
Secondary	Actigraphy	Motion watch-based objective measure of gross sleep temporal parameters (total sleep time, sleep latency, wakenings after sleep onset, sleep efficiency)	5 weeks
Secondary	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
Secondary	Pittsburgh Sleep Quality Index	Gives a score of 0-21 with higher score indicating worse sleep quality	5 weeks
Secondary	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
Secondary	Multidimensional Fatigue Inventory	Gives a score of 20-100, with higher scores indicating a higher level of fatigue	5 weeks
Secondary	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