Ignite Creation Date:
2025-12-24 @ 12:10 PM
Ignite Modification Date:
2026-01-26 @ 2:49 AM
Study NCT ID:
NCT04176861
Status:
COMPLETED
Last Update Posted:
2023-05-17
First Post:
2019-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
hBET for Pain and Sleep Feasibility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-15', 'studyFirstSubmitDate': '2019-11-18', 'studyFirstSubmitQcDate': '2019-11-22', 'lastUpdatePostDateStruct': {'date': '2023-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Qualitative semi-structured interviews', 'timeFrame': '5 weeks', 'description': 'Interview at end of intervention period, following an interview guide, with responses thematically analysed'}], 'secondaryOutcomes': [{'measure': 'Sleep and pain diary', 'timeFrame': '5 weeks', 'description': 'Bespoke daily diary recording self reported pain and sleep'}, {'measure': 'Actigraphy', 'timeFrame': '5 weeks', 'description': 'Motion watch-based objective measure of gross sleep temporal parameters (total sleep time, sleep latency, wakenings after sleep onset, sleep efficiency)'}, {'measure': 'Brief Pain Inventory', 'timeFrame': '5 weeks', 'description': 'Gives two scores of 0-10 for pain severity and pain interference respectively, with 10 being worst in both cases.'}, {'measure': 'Pittsburgh Sleep Quality Index', 'timeFrame': '5 weeks', 'description': 'Gives a score of 0-21 with higher score indicating worse sleep quality'}, {'measure': 'Hospital Anxiety and Depression Scale', 'timeFrame': '5 weeks', 'description': 'Gives two scores of 0-21 for depression and anxiety respectively, with 21 being worst in both cases'}, {'measure': 'Multidimensional Fatigue Inventory', 'timeFrame': '5 weeks', 'description': 'Gives a score of 20-100, with higher scores indicating a higher level of fatigue'}, {'measure': 'EuroQol 5 Dimensions (EQ-5D-5L)', 'timeFrame': '5 weeks', 'description': '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['audio-visual stimulation', 'brainwave entrainment'], 'conditions': ['Pain, Chronic', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '36910250', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': "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.\n\nThe 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.\n\nTherefore 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.\n\nThese 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic non-cancer pain (recurring pain ≥ 3 months duration)\n* Having nocturnal pain (NRS 0-10 worst pain ≥ 4)\n* 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\n\nExclusion Criteria:\n\n* Planned intervention (injection/ surgery/ new oral medications for pain or sleep) during the 4-week hBET use period\n* Seizure disorder\n* Photosensitivity\n* Hearing or sight problems causing inability to use hBET\n* Cognitive problems or dementia or mental health disorders causing inability to consent'}, 'identificationModule': {'nctId': 'NCT04176861', 'briefTitle': 'hBET for Pain and Sleep Feasibility', 'organization': {'class': 'OTHER', 'fullName': 'University of Manchester'}, 'officialTitle': 'Home-based Brainwave Entrainment Technology (hBET) for Management of Chronic Pain and Sleep Disturbance: A Feasibility Study.', 'orgStudyIdInfo': {'id': 'NHS001542'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home based intervention', 'description': 'Participants using hBET technology at home (all participants).', 'interventionNames': ['Device: home-based Brainwave Entrainment Technology']}], 'interventions': [{'name': 'home-based Brainwave Entrainment Technology', 'type': 'DEVICE', 'description': 'Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights', 'armGroupLabels': ['Home based intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M13 9PL', 'city': 'Manchester', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University of Manchester', 'geoPoint': {'lat': 53.48095, 'lon': -2.23743}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Manchester', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Leeds', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Visiting Clinical Research Fellow', 'investigatorFullName': 'Stephen Halpin', 'investigatorAffiliation': 'University of Manchester'}}}}