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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-04

Study Completion Date

2024-11-27

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Pain Insomnia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No