Alpha Entrainment for Pain and Sleep (Extension)

Pain, Chronic Clinical Trial

Official title:

Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699837
• Other study ID #: NHS001542(2)
• Status: Recruiting
• Phase: N/A
• Start date: September 19, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2023
• Source: University of Manchester
• Contact: Stephen J Halpin
• Phone: 01133922531
• Email: stephen.halpin[@]manchester.ac.uk
• 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. In a recent study the investigators found that these tools can be reliably used in home settings and there were some indications that they improved symptoms. However, sleep was only measured with sleep diary and movement detection, there was no direct measurement of whether the stimulation frequencies were resulting in the desired brainwave changes. Finally, the benefit to symptoms may have been the result of other factors, such as the passage of time or placebo effect.

Therefore this study extends the experiment, adding more accurate sleep monitoring which includes monitoring electrical activity in the brain (EEG), as well as providing rhythmic and non-rhythmic stimulation in a randomised order. The aim is to further test the effect of these home-based tools with individuals with long-term pain, in a more rigorous way. Up to 30 participants with long-term pain and pain-related sleep disturbance will use the tools for 30 minutes at bed time every day for 4 weeks (2 weeks with one type of stimulation, 2 weeks with another type). The changes in participants' pain, sleep, brainwave frequencies, fatigue and mood will be measured.

These findings will inform the planning and design of a future much larger study to test this technology, if this is justified by the results.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18-80 years

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

• Diagnosis of fibromyalgia, meeting 2016 ACR criteria.

• 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 during the study 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

• Night shift worker

• Any known primary sleep disorder including obstructive sleep apnoea, narcolepsy, restless leg syndrome

Related Conditions & MeSH terms

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

Intervention

Device:
• Audio or visual alpha (10Hz) stimulation
Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights, to deliver rhythmic 10Hz or non-rhythmic stimulation

Locations

Country	Name	City	State
United Kingdom	Leeds Community Healthcare NHS Trust	Leeds
United Kingdom	University of Manchester	Manchester	England

Sponsors (3)

Lead Sponsor	Collaborator
University of Manchester	University of Leeds, University of Warwick

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in alpha power from baseline	Alpha spectral power in active stimulation use periods compared to sham stimulation use periods relative to equivalent baseline periods.	Daily for 6 weeks
Primary	Change in Sleep Quality from baseline, measured with Pittsburgh Sleep Quality Index	Sleep quality (0-21 score) at the end of 2 week active stimulation use period compared to at the end of 2 week sham stimulation use period each relative to the baseline period.	Weeks 1, 3 and 6
Secondary	Daily pain diary	pain over 24 hours and at night (0-10 NRS)	Daily for 6 weeks
Secondary	Daily sleep diary; total sleep time	Total sleep time (minutes)	Daily for 6 weeks
Secondary	DREEM headband; total sleep time	Total sleep time (minutes)	Daily for 6 weeks
Secondary	Actigraphy; total sleep time	Total sleep time (minutes)	Daily for 6 weeks
Secondary	Daily sleep diary; sleep onset latency	Sleep onset latency (minutes)	Daily for 6 weeks
Secondary	DREEM headband; sleep onset latency	Sleep onset latency (minutes)	Daily for 6 weeks
Secondary	Actigraphy; sleep onset latency	Sleep onset latency (minutes)	Daily for 6 weeks
Secondary	Daily sleep diary; Wake after sleep onset	Wake after sleep onset (minutes)	Daily for 6 weeks
Secondary	DREEM Headband; Wake after sleep onset	Wake after sleep onset (minutes)	Daily for 6 weeks
Secondary	Actigraphy; Wake after sleep onset	Wake after sleep onset (minutes)	Daily for 6 weeks
Secondary	Daily sleep diary; Sleep Efficiency	sleep efficiency (%)	Daily for 6 weeks
Secondary	DREEM headband; Sleep Efficiency	sleep efficiency (%)	Daily for 6 weeks
Secondary	Actigraphy; Sleep Efficiency	sleep efficiency (%)	Daily for 6 weeks
Secondary	Daily sleep diary; Sleep quality	Rating of quality (0-5 NRS) and refreshed (0-5 NRS)	Daily for 6 weeks
Secondary	DREEM headband derived sleep architecture	Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)	Daily for 6 weeks
Secondary	DREEM headband derived microarousal index	Microarousal frequency (events/hour)	Daily for 6 weeks
Secondary	DREEM headband recorded awakenings	Awakenings (number)	Daily for 6 weeks
Secondary	Brief Pain Inventory Pain Interference score	0-10 NRS for pain interference	Weekly for 6 weeks
Secondary	Brief Pain Inventory Severity score	0-10 NRS for pain severity	Weekly for 6 weeks
Secondary	Hospital Anxiety and Depression Scale	Scores of 0-21 for anxiety, 0-21 for depression	Weeks 1, 3 and 6
Secondary	Multidimensional Fatigue Inventory	Score of 20-100	Weeks 1, 3 and 6
Secondary	EuroQol 5 Dimensions (EQ-5D-5L)	0-1 global index score, 0-100 VAS score.	Weeks 1, 3 and 6