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