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

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06368531
• Other study ID #: 2314270
• Status: Recruiting
• Start date: April 4, 2024
• Est. completion date: August 15, 2025

Study information

• Verified date: April 2024
• Source: Odense University Hospital
• Contact: Henrik B Vaegter, PhD
• Phone: 004565413869
• Email: hbv[@]rsyd.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: August 15, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Insomnia

Locations

Country	Name	City	State
Denmark	Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense	Odense

Sponsors (3)

Lead Sponsor	Collaborator
Odense University Hospital	T&W Engineering A/S, University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	Age		Baseline
Other	Sex		Baseline
Other	Ethnicity		Baseline
Other	Height		Baseline
Other	Weight		Baseline
Other	Level of education		Baseline
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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