protocolSection identificationModule nctId: NCT06368531, orgStudyIdInfo id: 2314270, briefTitle: Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-04, primaryCompletionDateStruct date: 2025-02-15, completionDateStruct date: 2025-08-15, studyFirstPostDateStruct date: 2024-04-16, lastUpdatePostDateStruct date: 2024-04-16, sponsorCollaboratorsModule leadSponsor name: Odense University Hospital, class: OTHER, collaborators name: University of Aarhus, collaborators name: T&W Engineering A/S, descriptionModule briefSummary: Insomnia is reported by more than 50% of patients with chronic pain. In this study, the investigators aim to advance the understanding of physiological sleep in individuals with chronic pain. To do this the investigators will monitor at-home sleep with an ear-EEG over 20 nights in patients with chronic pain and collect self-reported measures of sleep and pain. The collected data will be used to explore and characterize intra-individual variations in sleep metrics (e.g. total sleep time, time in each sleep stage (N1, N2, N3, REM), sleep latency, REM stage latency, wake after sleep onset, sleep efficiency, number of arousals and arousal index) over 20 nights., conditionsModule conditions: Chronic Pain, conditions: Insomnia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 25, type: ESTIMATED, outcomesModule primaryOutcomes measure: sleep period time (SPT) from Ear EEG, primaryOutcomes measure: Qualitative sleep parameters obtained from sleep diary., primaryOutcomes measure: Pain intensity rating, primaryOutcomes measure: Time from sleep onset until final awakening (TST) from Ear EEG, primaryOutcomes measure: Sleep efficiency (SE) from Ear EEG, primaryOutcomes measure: Sleep onset latency (SOL) from Ear EEG, primaryOutcomes measure: Wake after sleep onset (WASO) from Ear EEG, primaryOutcomes measure: REM sleep latency from Ear EEG, primaryOutcomes measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG, primaryOutcomes measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG, primaryOutcomes measure: Number of awakenings within TST from Ear EEG, primaryOutcomes measure: Arousal index which is number of arousals per hour from Ear EEG, secondaryOutcomes measure: Ease-of-use and Comfort with ear EEG, secondaryOutcomes measure: Adverse device effects, secondaryOutcomes measure: Polysomnography, otherOutcomes measure: Sleep quality, otherOutcomes measure: Insomnia, otherOutcomes measure: The Graded Chronic Pain Scale Revised, otherOutcomes measure: Age, otherOutcomes measure: Sex, otherOutcomes measure: Ethnicity, otherOutcomes measure: Height, otherOutcomes measure: Weight, otherOutcomes measure: Level of education, otherOutcomes measure: Obstructive sleep apnea, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense, status: RECRUITING, city: Odense, zip: 5000, country: Denmark, contacts name: Henrik B Vaegter, PhD, role: CONTACT, phone: 004565413869, geoPoint lat: 55.39594, lon: 10.38831, hasResults: False