Chronic Pain, Insomnia
Conditions
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.
Interventions
None listed
Sponsors
T&W Engineering A/S
University of Aarhus
Odense University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
For a subject to be eligible, all
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| REM sleep latency from Ear EEG | 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 onset latency (SOL) from Ear EEG | 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 | 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 | 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 | 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). |
| Pain intensity rating | 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) |
| Qualitative sleep parameters obtained from sleep diary. | Sleep diary is completed 5 mornings every week for 4 weeks | Sleep diary is completed in the morning |
| sleep period time (SPT) from Ear EEG | 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 | 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% |
| Time from sleep onset until final awakening (TST) from Ear EEG | 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 | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography | Baseline | 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. |
| Ease-of-use and Comfort with ear EEG | Completed every morning after ear EEG first 2 weeks and at end of study | 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. |
| Adverse device effects | Baseline, after 2 weeks, after 6 weeks | Any adverse device effect defined as an adverse effect related to the use of the ear EEG |
Other
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | Baseline | Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI), which is developed to provide a reliable, valid and standardized measure of sleep quality. The PSQI consists of 19 items with 15 multiple choice questions and 4 open-ended questions. The 19 items form the basis a global score. The seven components evaluated by the PSQI are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medications and daytime dysfunction. Each component has a score ranging from 0 to 3 yielding a total score of 21, with higher scores reflecting worse sleep difficulties |
| Obstructive sleep apnea | Baseline | Risk for obstructive sleep apnea (OSA) will be evaluated with the snoring history, tired during the day, observed stop of breathing while sleeping, high blood pressure, BMI \> 35 kg/m2 (or 30 kg/m2), age \> 50 years, neck circumference \> 40 cm and male gender) questionnaire (The STOP-BANG). The STOP-BANG questionnaire is a four item forced yes/no questionnaire. |
| Level of education | Baseline | — |
| Weight | Baseline | — |
| Height | Baseline | — |
| Ethnicity | Baseline | — |
| Sex | Baseline | — |
| Age | Baseline | — |
| The Graded Chronic Pain Scale Revised | Baseline | The Graded Chronic Pain Scale Revised (GCPS-R) is a brief, freely available questionnaire that assesses frequency and severity of pain and its impact. The GCPS-R uses 5 items to categorize pain into mild chronic pain, bothersome chronic pain, and high-impact chronic pain |
| Insomnia | Baseline | Insomnia will be assessed with the Insomnia Severity Index (ISI) which encompasses seven items measuring severity of sleep-onset; sleep maintenance and early morning awakening difficulties; satisfaction with sleep patterns; daily function interference; impairments due to sleep problems; and distress or concerns due to sleep problems. Each item is rated from 0 to 4 (0 = no problem, 4 = severe problem), yielding a total score of 28, with higher scores reflecting worse insomnia |
Countries
Denmark
Outcome results
None listed