Clinical trial NCT06368531: Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
Official title: Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Insomnia
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: T&W Engineering A/S
name: University of Aarhus
First posted: 2024-04-16
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: sleep period time (SPT) from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Qualitative sleep parameters obtained from sleep diary.
timeFrame: Sleep diary is completed 5 mornings every week for 4 weeks
measure: Pain intensity rating
timeFrame: Pain intensity rating is completed 5 mornings every week for 4 weeks
measure: Time from sleep onset until final awakening (TST) from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Sleep efficiency (SE) from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Sleep onset latency (SOL) from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Wake after sleep onset (WASO) from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: REM sleep latency from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Time from sleep onset until first epoch of REM stage sleep from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Amount of wake and stage N1, N2, N3, and R sleep as a percentage of SPT from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Number of awakenings within TST from Ear EEG
timeFrame: 5 nights every week for 4 weeks
measure: Arousal index which is number of arousals per hour from Ear EEG
timeFrame: 5 nights every week for 4 weeks
Secondary outcomes:
measure: Ease-of-use and Comfort with ear EEG
timeFrame: Completed every morning after ear EEG first 2 weeks and at end of study
measure: Adverse device effects
timeFrame: Baseline, after 2 weeks, after 6 weeks
measure: Polysomnography
timeFrame: Baseline
Other outcomes:
measure: Sleep quality
timeFrame: Baseline
measure: Insomnia
timeFrame: Baseline
measure: The Graded Chronic Pain Scale Revised
timeFrame: Baseline
measure: Age
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
measure: Level of education
timeFrame: Baseline
measure: Obstructive sleep apnea
timeFrame: Baseline
Locations:
city: Odense
country: Denmark
facility: Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
Study officials:
affiliation: University Hospital Odense
name: Henrik B Vægter, PhD
role: PRINCIPAL_INVESTIGATOR
References: