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Alpha Entrainment for Pain and Sleep (Extension)

Primary Purpose

Pain, Chronic, Sleep Disturbance

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Audio or visual alpha (10Hz) stimulation
Sponsored by
University of Manchester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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

Sites / Locations

  • University of ManchesterRecruiting
  • Leeds Community Healthcare NHS TrustRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

hBET 1

hBET 2

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Daily pain diary
pain over 24 hours and at night (0-10 NRS)
Daily sleep diary; total sleep time
Total sleep time (minutes)
DREEM headband; total sleep time
Total sleep time (minutes)
Actigraphy; total sleep time
Total sleep time (minutes)
Daily sleep diary; sleep onset latency
Sleep onset latency (minutes)
DREEM headband; sleep onset latency
Sleep onset latency (minutes)
Actigraphy; sleep onset latency
Sleep onset latency (minutes)
Daily sleep diary; Wake after sleep onset
Wake after sleep onset (minutes)
DREEM Headband; Wake after sleep onset
Wake after sleep onset (minutes)
Actigraphy; Wake after sleep onset
Wake after sleep onset (minutes)
Daily sleep diary; Sleep Efficiency
sleep efficiency (%)
DREEM headband; Sleep Efficiency
sleep efficiency (%)
Actigraphy; Sleep Efficiency
sleep efficiency (%)
Daily sleep diary; Sleep quality
Rating of quality (0-5 NRS) and refreshed (0-5 NRS)
DREEM headband derived sleep architecture
Duration in and latency to (minutes) and proportion (%) in each stage (N1, N2, N3, REM)
DREEM headband derived microarousal index
Microarousal frequency (events/hour)
DREEM headband recorded awakenings
Awakenings (number)
Brief Pain Inventory Pain Interference score
0-10 NRS for pain interference
Brief Pain Inventory Severity score
0-10 NRS for pain severity
Hospital Anxiety and Depression Scale
Scores of 0-21 for anxiety, 0-21 for depression
Multidimensional Fatigue Inventory
Score of 20-100
EuroQol 5 Dimensions (EQ-5D-5L)
0-1 global index score, 0-100 VAS score.

Full Information

First Posted
November 22, 2022
Last Updated
January 16, 2023
Sponsor
University of Manchester
Collaborators
University of Leeds, University of Warwick
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1. Study Identification

Unique Protocol Identification Number
NCT05699837
Brief Title
Alpha Entrainment for Pain and Sleep (Extension)
Official Title
Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: EEG Extension to a Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 19, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manchester
Collaborators
University of Leeds, University of Warwick

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Chronic, Sleep Disturbance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen J Halpin
Phone
01133922531
Email
stephen.halpin@manchester.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anthony KP Jones
Organizational Affiliation
University of Manchester
Official's Role
Study Director
Facility Information:
Facility Name
University of Manchester
City
Manchester
State/Province
England
ZIP/Postal Code
M13 9PL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen J Halpin
Phone
01133922531
Email
stephen.halpin@manchester.ac.uk
Facility Name
Leeds Community Healthcare NHS Trust
City
Leeds
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen J Halpin
Phone
01133922531
Email
stephen.halpin@manchester.ac.uk

12. IPD Sharing Statement

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Alpha Entrainment for Pain and Sleep (Extension)

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