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

NCT06368531 | Completed

• 1 other identifier: 2314270
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Insomnia

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (3)

• Ease-of-use and Comfort with ear EEG

  Completed every morning after ear EEG first 2 weeks and at end of study

• Adverse device effects

  Baseline, after 2 weeks, after 6 weeks

• Polysomnography

  Baseline

Other Outcomes (10)

• Sleep quality

  Baseline

• Insomnia

  Baseline

• The Graded Chronic Pain Scale Revised

  Baseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Odense University Hospital: lead
• T&W Engineering A/S: collaborator
• University of Aarhus: collaborator

Study Sites (1)

Pain Center, Department of Anesthesiology and Intensive Care Medicine, University Hospital Odense

Odense, 5000, Denmark

Location

MeSH Terms

Conditions

Chronic Pain; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Henrik B Vægter, PhD

  University Hospital Odense

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2024
• First Posted: April 16, 2024
• Study Start: April 4, 2024
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

DK (1)