Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
- Conditions
- InsomniaChronic Pain
- Registration Number
- NCT06368531
- Lead Sponsor
- Odense University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 25
For a subject to be eligible, all inclusion criteria must be answered "yes":
- Understand and write Danish.
- Pain present on most days or every day during the past 3 months.
- Pain limits daily activities or work on some days, most days or every day during the past 3 months.
- Pain intensity equal to or larger than 4 on 0-10 Numeric Rating Scale [NRS] within the last week.
- Informed consent obtained before any study related activities.
For a subject to be eligible, all exclusion criteria must be answered "no":
- Previous stroke or cerebral haemorrhage and any other structural cerebral disease.
- Obstructive sleep apnoea (Defined as yes to 3 or more questions in the STOP-BANG questionnaire for women and 4 or more questions for men).
- Teeth grinding (bruxism).
- Pregnancy or lactation (Pregnancy is screened for through self-reporting as no risks regarding pregnancy have been identified for the described study procedures).
- Narrow or malformed ear canals or piercings, making ear-EEG infeasible.
- Allergic contact dermatitis caused by metals or generally prone to skin irritation.
- People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Qualitative sleep parameters obtained from sleep diary. Sleep diary is completed 5 mornings every week for 4 weeks Sleep diary is completed in the morning
Sleep onset latency (SOL) from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Wake after sleep onset (WASO) from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Sleep efficiency (SE) from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM). SE is the ratio of TST to time in bed / 100%
sleep period time (SPT) from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Arousal index which is number of arousals per hour from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Pain intensity rating Pain intensity rating is completed 5 mornings every week for 4 weeks Average pain intensity during the last day and current pain intensity in the morning will be assessed on an 11-point numeric rating scale (NRS) ranging from 0 (no pain) to 10 (worst imaginable pain)
Time from sleep onset until final awakening (TST) from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Time from sleep onset until first epoch of REM stage sleep from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Number of awakenings within TST from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
REM sleep latency from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG 5 nights every week for 4 weeks Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).
- Secondary Outcome Measures
Name Time Method Ease-of-use and Comfort with ear EEG Completed every morning after ear EEG first 2 weeks and at end of study Three 0-10 questions are used: 1) How did you experience falling asleep with the ear EEG device, 2) How did you experience sleeping with the ear EEG device?, 3) How would you rate your experience of soreness or discomfort in your ears after sleeping with the device? A lower sum score is worse.
Adverse device effects Baseline, after 2 weeks, after 6 weeks Any adverse device effect defined as an adverse effect related to the use of the ear EEG
Polysomnography Baseline Polysomnography (PSG) is used in this study to ensure that the data that comes out of the automatic ear-EEG based sleep scoring matches the clinicians sleep scores based on the PSG. It will enable further development of the existing algorithm for automating the data analysis.
Trial Locations
- Locations (1)
Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
🇩🇰Odense, Denmark