Long-term Monitoring of Sleep with Ear-EEG in Patients with Chronic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Qualitative sleep parameters obtained from sleep diary.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •For a subject to be eligible, all exclusion criteria must be answered "no":
- •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.
结局指标
主要结局
Qualitative sleep parameters obtained from sleep diary.
时间窗: Sleep diary is completed 5 mornings every week for 4 weeks
Sleep diary is completed in the morning
Sleep onset latency (SOL) from Ear EEG
时间窗: 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
时间窗: 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
时间窗: 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%
sleep period time (SPT) from Ear EEG
时间窗: 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
时间窗: 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
时间窗: 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)
Time from sleep onset until final awakening (TST) from Ear EEG
时间窗: 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
时间窗: 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
时间窗: 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).
REM sleep latency from Ear EEG
时间窗: 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
时间窗: 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).
次要结局
- 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)