SLEEPINESS - a Search for a Biomarker of Excessive Daytime Sleepiness in Severe Obstructive Sleep Apnoea - An Explorative Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Ultra long-term EEG derived sleepiness biomarker
研究概览
简要总结
Study aim:
This study aims to use a new brainwave monitoring device that meassure brainwaves 24 hours a day to create better understanding of sleep-wake interplay as a biomarker for excessive daytime sleepiness because of obstructive sleep apnea.
Study Method, Design, and Procedures Patients with sleep apnea referred to the Sleep Clinic at the Department of Ear, Nose, Throat, and Jaw Surgery in Køge for CPAP treatment, who also experience severe daytime sleepiness, will be offered participation in this study. The goal is for 15 participants to complete the entire protocol.
Procedure Overview Initial Sleep Assessment: The study begins with an in-depth sleep assessment through polysomnography (PSG) followed by a Multiple Sleep Latency Test (MSLT).
PSG: This sleep study evaluates sleep structure, confirms sleep apnea, and rules out other sleep disorders.
MSLT: This test measures the brain's tendency to fall asleep during the day. Additional Home-Based Sleep Studies: Participants will undergo two more PSG studies in their homes.
EEG Monitoring: After the initial assessments, participants will have a small EEG electrode implanted to monitor brain activity.
The implant, a CE-certified device called 24/7 EEG™ SubQ, will be inserted under local anesthesia by an experienced surgeon.
Once post-surgery swelling subsides (after about 7-10 days), continuous EEG monitoring will begin, where participants connect an external data storage device during the day. The device records for 12 weeks, and CPAP treatment begins around the 6-week mark.
After 12 weeks, the EEG device is removed, and the study ends. Aditional Data Collection (Optional)
During the 12 weeks of EEG recording, participants are asked to report:
Sleep Diary: Log daytime sleep episodes, including planned naps and unintended naps.
Questionnaires and Tests: Complete daily questionnaires about fatigue symptoms and perform a brief attention and reaction test. These tasks take 3-10 minutes each day and are accessible via smartphone or tablet.
Interviews and Movement Tracking: Participants may also be invited to interviews on how sleepiness affects their daily life and asked to wear a motion-tracking watch to monitor activity.
详细描述
2.1 Background Sleep quality and quantity is essential for a healthy life. One prominent spoiler of good sleep quality is sleep fragmentation duo to sleep disordered breathing like obstructive sleep apnoea (OSA). A recent global estimation of OSA prevalence estimated that close to 1 billion people suffer from OSA. With a global population of advancing age and increasing obesity the global OSA prevalence seems at a rise.
The health-related consequences of OSA are many; Surge towards metabolic syndrome and an increased cardiovascular risk is well established within the scientific literature. But very invalidating is the inability to obtain restorative sleep through the night and its daytime fellow excessive daytime sleepiness (EDS) which is a key feature for some OSA patient. This reduces quality of life, work ability and general cognitive function as well as driving performance. Furthermore EDS has been is linked to increased comorbidity and mortality.
The American Academy of Sleep Medicine (AASM) defines EDS as "the inability to maintain wakefulness and alertness during the major waking episodes of the day, with sleep occurring unintentionally or at inappropriate times almost daily for at least three months"
3 Study design - overview 3.1 Description of study design This study is an exploratory study in severe OSA patients with EDS defined as an ESS > 10 to record ultra-long-term EEG data with a subcutaneous EEG electrode 6 weeks prior to starting CPAP treatment and 6 weeks after initiation of CPAP treatment. The scope is to detect and quantify episodes of sleep phenomena during normal daytime and study CPAP related sleep rehabilitation.
The hypothesis is that the recordings will show episodes of daytime lapses into sleep both registered by the subject but also episodes of EEG recordings with sleep phenomena that will not be registered by the subject. We hypothesise that CPAP treatment will decrease the quantity of these events in a dose dependant manner. Can this be used as a biomarker for EDS in OSA patients? Is this biomarker stable for patients who do not experience a reduction in ESS when they start CPAP? Will the reduction in EEG recorded sleep phenomenons follow a reduction in other sleepiness scores or sleepiness related cognitive performance? The study period will be running over a period of approximately 4 months from inclusion to completion of the study. The subject enrolled will follow the ordinary patient flow for new referrals within the sleep clinic. The participation in the study will not postpone the timeframe within the OSA patient normally starts CPAP treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（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":
- •Age ≥18 years
- •Subjects must be diagnosed with Severe Obstructive Sleep Apnea (AHI > 30) and have not yet started any form of PAP (positive airway pressure) treatment.
- •ESS score must be above 10 at the time of inclusion.
排除标准
- •For a subject to be eligible, all exclusion criteria must be answered "no":
- •Known severe neurological or psychiatric diseases.
- •Known congestive heart failure, chronic renal failure, liver failure, malignancy, severe pulmonary disease.
- •Considerable use of alcohol.
- •Medication judged by investigator to influence sleep/wake regulation to such a degree that data quality will be compromised.
- •Has cochlear implants.
- •Involved in therapies with medical devices that deliver electrical energy into the area around the implant.
- •Is at high risk of surgical complications, such as active systemic infection and haemorrhagic disease.
- •Are unable (i.e. mentally or physically impaired patient), or do not have the necessary assistance, to properly operate the device system.
- •Has an infection at the site of device implantation.
- •Operates MRI scanners.
- •Has a profession/hobby that includes activity imposing extreme pressure variations (e.g. diving or parachute jumping). NB: diving/snorkelling is allowed to 5 metres depth.
- •Has a profession/hobby that includes activity imposing an unacceptable risk for trauma against the device or the site of implantation (e.g. martial art or boxing).
- •Other known diseases or conditions, judged by investigator to influence sleep to such a degree that data quality will be compromised.
- •Incapable, judged by the investigator, of understanding the participant instruction or who are not capable of carrying through the investigation.
- •Pregnancy or intention to become pregnant within the next 12 months.
结局指标
主要结局
Ultra long-term EEG derived sleepiness biomarker
时间窗: From enrollment to completion 4 months
Our primary explorative objective is to scrutinize subcutaneous Ultra Long-term EEG for potential biomarkers predicting sleepiness in OSA patients. Determining daytime wake-to-sleep transition rate, episodes of microsleep, and episodes of macro sleep, alongside the duration and patterns of these events. Our explorative findings will be correlated and preliminary validated against the well-established sleepiness metrics and questionnaires, multiple sleep latency test (MSLT), Epworth Sleepiness scale (ESS), Karolinska Sleepiness Scale (KSS), and a 3-minute psycomotor vigilance tast test (PVT), as well as to the patient's experience of falling asleep or dozing off intentionally and unintentionally in the form of a "sleep and nap diary". Any potential sleepiness biomarker derived from this study will be available for future confirmatory trials.
The effects of CPAP treatment on ultra long-term EEG
时间窗: From enrollment to completion 4 months
Our experimental objective is to determine the effects of CPAP treatment on sleep quality, quantity, and timing from the day-to-day perspective that ULT-EEG provides. Furthermore, the experimental design enables us to clinically validate the exploratively deduced sleepiness biomarker candidates through comparisons before and after the intervention of CPAP treatment conditions. Previous studies on the effect of CPAP on sleepiness reduction have shown a dose-dependent configuration with CPAP usage. ESS is typically reduced by 4,78 (or more). We expect relevant biomarker candidates to follow similar patterns when CPAP is introduced in a population with severe OSA and EDS.
次要结局
- Validate automatic sleep/wake classification from ultra long-term EEG for patients with severe obstructive sleep apnea(From enrollment to completion 4 months)