Long-term Monitoring of Sleep With Ear-EEG in Patients With Chronic Pain

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pain; Insomnia

• Study Type: Observational
• Enrollment (Estimated): 25

Contacts and Locations

• Study Contact: Name: Henrik B Vaegter, PhD; Phone Number: 004565413869; Email: hbv@rsyd.dk

Study Locations

• Denmark
  • Odense, Denmark, 5000
    • Recruiting
    • Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
    • Contact: Henrik B Vaegter, PhD; Phone Number: 004565413869

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects eligible for this study are individuals with chronic pain in compliance with the inclusion/exclusion criteria listed below. The health status of the subjects is assessed by self-reports.

Inclusion and exclusion criteria ensure generalizability of study results for a broad population of individuals with chronic pain, and only serious concomitant conditions, which could interfere with the study procedures should prevent subjects from entering the study.

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleep period time (SPT) from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Qualitative sleep parameters obtained from sleep diary.	Sleep diary is completed in the morning	Sleep diary is completed 5 mornings every week for 4 weeks
Pain intensity rating	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)	Pain intensity rating is completed 5 mornings every week for 4 weeks
Time from sleep onset until final awakening (TST) from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Sleep efficiency (SE) from Ear EEG	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%	5 nights every week for 4 weeks
Sleep onset latency (SOL) from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Wake after sleep onset (WASO) from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
REM sleep latency from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Time from sleep onset until first epoch of REM stage sleep from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Number of awakenings within TST from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks
Arousal index which is number of arousals per hour from Ear EEG	Sleep metrics will be derived from the EEG assessments as recommended by the American Academy of Sleep Medicine (AASM).	5 nights every week for 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ease-of-use and Comfort with ear EEG	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.	Completed every morning after ear EEG first 2 weeks and at end of study
Adverse device effects	Any adverse device effect defined as an adverse effect related to the use of the ear EEG	Baseline, after 2 weeks, after 6 weeks
Polysomnography	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.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Height		Baseline
Weight		Baseline
Age		Baseline
Sex		Baseline
Ethnicity		Baseline
Sleep quality	Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), which is developed to provide a reliable, valid and standardized measure of sleep quality. The PSQI consists of 19 items with 15 multiple choice questions and 4 open-ended questions. The 19 items form the basis a global score. The seven components evaluated by the PSQI are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications and daytime dysfunction. Each component has a score ranging from 0 to 3 yielding a total score of 21, with higher scores reflecting worse sleep difficulties	Baseline
Insomnia	Insomnia will be assessed with the Insomnia Severity Index (ISI) which encompasses seven items measuring severity of sleep-onset; sleep maintenance and early morning awakening difficulties; satisfaction with sleep patterns; daily function interference; impairments due to sleep problems; and distress or concerns due to sleep problems. Each item is rated from 0 to 4 (0 = no problem, 4 = severe problem), yielding a total score of 28, with higher scores reflecting worse insomnia	Baseline
The Graded Chronic Pain Scale Revised	The Graded Chronic Pain Scale Revised (GCPS-R) is a brief, freely available questionnaire that assesses frequency and severity of pain and its impact. The GCPS-R uses 5 items to categorize pain into mild chronic pain, bothersome chronic pain, and high-impact chronic pain	Baseline
Level of education		Baseline
Obstructive sleep apnea	Risk for obstructive sleep apnea (OSA) will be evaluated with the snoring history, tired during the day, observed stop of breathing while sleeping, high blood pressure, BMI > 35 kg/m2 (or 30 kg/m2), age > 50 years, neck circumference > 40 cm and male gender) questionnaire (The STOP-BANG). The STOP-BANG questionnaire is a four item forced yes/no questionnaire.	Baseline

Collaborators and Investigators

• Sponsor: Odense University Hospital
• Collaborators: University of Aarhus; T&W Engineering A/S
• Investigators: Principal Investigator: Henrik B Vægter, PhD, University Hospital Odense

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): August 15, 2025

Study Registration Dates

• First Submitted: March 26, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain
• Other Study ID Numbers: 2314270

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No