Alpha Entrainment for Pain and Sleep (Extension)

NCT05699837 | Completed

• 1 other identifier: NHS001542(2)
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

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. 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.

Conditions

Pain, Chronic; Sleep Disturbance

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (22)

• Daily pain diary

  Daily for 6 weeks

• Daily sleep diary; total sleep time

  Daily for 6 weeks

• DREEM headband; total sleep time

  Daily for 6 weeks

• Actigraphy; total sleep time

  Daily for 6 weeks

• Daily sleep diary; sleep onset latency

  Daily for 6 weeks

Study Arms (2)

hBET 1

EXPERIMENTAL

Rhythmic stimulation (2 weeks) followed by non-rhythmic stimulation (2 weeks)

Device: Audio or visual alpha (10Hz) stimulation

hBET 2

EXPERIMENTAL

Non-rhythmic stimulation (2 weeks) followed by rhythmic stimulation (2 weeks)

Device: Audio or visual alpha (10Hz) stimulation

Interventions

Audio or visual alpha (10Hz) stimulation DEVICE

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

hBET 1; hBET 2

Eligibility Criteria

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

You may qualify if:

• 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 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 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

Sponsors & Collaborators

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

Study Sites (2)

University of Manchester

Manchester, England, M13 9PL, United Kingdom

Location

Leeds Community Healthcare NHS Trust

Leeds, United Kingdom

Location

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 Officials

• Anthony KP Jones

  University of Manchester

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The stimulation is delivered via a smartphone application. Each participant will receive one of two versions, which are identical apart from the order in which the two types of stimulation are given. The participant and the investigator enrolling participants and conducting questionnaire and interview outcome assessment, will be masked as to which version they are using. The record of which version was allocated to which participant will be held centrally by co-investigators with no direct participant contact, until results are analysed.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Following a baseline period each participant will use two types of sensory stimulation for two weeks, in a randomised order, with a 1 week washout period.

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: January 26, 2023
• Study Start: September 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Locations

GB (2)