Under construction – not a live service
Sign in
CompletedNo phase

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

Key facts

Who runs it
Odense University Hospital
Where
Denmark1 site in 1 countryChoose a country to see its sites
Trial code
Status
Completed
People taking part
25 people enrolled
Started
4 Apr 2024
Ended
27 Nov 2024
Type of study
Observational
Record updated
24 March 2025

Who can take part

Age
18 years to 65 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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 take part

  • Previous stroke or cerebral haemorrhage and any other structural cerebral disease
  • Allergic contact dermatitis caused by metals or generally prone to skin irritation
  • For a subject to be eligible, all exclusion criteria must be answered "no":
  • 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
  • People judged incapable, by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
24 March 2025