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

Odense University Hospital25 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

Conditions

Chronic Pain Insomnia

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 5 nights every week for 4 weeks

Qualitative sleep parameters obtained from sleep diary.

Sleep diary is completed in the morning

Time frame: 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)

Time frame: 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).

Time frame: 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%

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 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).

Time frame: 5 nights every week for 4 weeks

Secondary Outcomes

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.

Time frame: 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

Time frame: 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.

Time frame: Baseline

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

Overview

Conditions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes