Chronic PainNCT06368531
Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
An observational study of Chronic Pain and Insomnia, run by Odense University Hospital at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Pain, Insomnia
- How many people
- 25 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Apr 2024to 27 Nov 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense
Odense, 5000
About this study
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.
- Conditions
- Chronic Pain, Insomnia
- Medical subject headings
- Chronic Pain, Sleep Initiation and Maintenance Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 nights every week for 4 weeks
Qualitative sleep parameters obtained from sleep diary.
Sleep diary is completed in the morning
Measured: 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)
Measured: 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).
Measured: 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%
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 5 nights every week for 4 weeks
Secondary outcomes (3)
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.
Measured: 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
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start4 Apr 2024
- Primary completion27 Nov 2024
- Study completion27 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Odense University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- T&W Engineering A/S, University of Aarhus
- Responsible party
- Sponsor
- Investigators
- Henrik B Vægter, PhD, Principal investigator, University Hospital Odense
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06368531
- Sponsor's protocol ID
- 2314270
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vaegter HB, Banluesombatkul N, Olsen MLS, Kilic K, Thomsen MD, Hemmsen MC, Kidmose P, Thorlund JB. Temporal Associations Between Physiological Sleep and Next-Day Pain Intensity in Individuals With Activity-Limiting Chronic Pain: A Multiple Night At-Home Ear-EEG Sleep-Monitoring Study. J Sleep Res. 2026 Nov 5:e70488. doi: 10.1111/jsr.70488. Online ahead of print.
PubMed 42984383
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
- ClinicalTrials.gov ID
- NCT06368531
- Acronym / sponsor ID
- 2314270
- Conditions
- Chronic Pain, Insomnia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Collaborators
- T&W Engineering A/S, University of Aarhus
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 27 Nov 2024 (actual)
- Study completion
- 27 Nov 2024 (actual)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
sleep period time (SPT) from Ear EEG
Time frame: 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).
Qualitative sleep parameters obtained from sleep diary.
Time frame: Sleep diary is completed 5 mornings every week for 4 weeks
Sleep diary is completed in the morning
Pain intensity rating
Time frame: 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
Time frame: 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
Time frame: 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 onset latency (SOL) from Ear EEG
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
3 secondary outcomes
Ease-of-use and Comfort with ear EEG
Time frame: Completed every morning after ear EEG first 2 weeks and at end of study
Adverse device effects
Time frame: Baseline, after 2 weeks, after 6 weeks
Polysomnography
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- Derived from this study: PubMed 42984383Vaegter HB, Banluesombatkul N, Olsen MLS, Kilic K, Thomsen MD, Hemmsen MC, Kidmose P, Thorlund JB. Temporal Associations Between Physiological Sleep and Next-Day Pain Intensity in Individuals With Activity-Limiting Chronic Pain: A Multiple Night At-Home Ear-EEG Sleep-Monitoring Study. J Sleep Res. 2026 Nov 5:e70488. doi: 10.1111/jsr.70488. Online ahead of print.
- Individual participant dataSharing planned: Undecided
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik B Vægter, PhD principal investigator
University Hospital Odense
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain and Insomnia, run by Odense University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sleep period time (SPT) from Ear EEG (time frame: 5 nights every week for 4 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06368531, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2025.