Validation of the Sleep Assessment Algorithm in the Medical Application Nightly and Comparing it to Polysomnography in 24 Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- The ICC for distribution of the total duration of standby periods during phases NREM and REM
研究概览
简要总结
The Nightly medical application prototype is a potential, non-invasive class I medical device. The application has the potential to combine both diagnostic and therapeutic procedures for sleep. At home, Nightly measures the user's motion during sleep and then records the sleep pattern from the received data. The obtained data are then used for the diagnosis of sleep disorders (REM and NREM sleep). Using acoustic and visual stimulation, the application has the capability to support the natural process of falling asleep, provide a better night's sleep by minimizing sleep deprivation and nightmares, while awakening the user at the appropriate moment (during light sleep).
详细描述
The study is a cohort, single-center, randomized trial. The duration of one participant included in the study is three successive nights. Visual analysis of polysomnographic recordings taken from the second and third nights will be performed independently by two independent, blinded experts. According to the sleep architecture description derived from the Nightly application, polysomnographic and actigraphy studies will be assessed using the intraclass correlation coefficient, ICC, version "Two-Way Random". Parameters of the sleep architecture will be the average total length of the individual sleep phases (provided with standard deviations and coefficients of variability defined as the quotient of standard deviation and mean).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any healthy individual who meets all the following criteria may be included in the study:
- •Age 18 to 40 years.
- •Signed Informed Consent Form for participation in the study
- •No chronic illnesses (A medical interview will be conducted during the participants first visit)
- •Does not take any medication chronically (According to the medical interview with the participants during the first visit)
排除标准
- •A person who meets any one of the following criteria cannot be included in the study:
- •Primary sleep disorders. (An in-depth medical interview during the first visit to be supplemented with: Holland Sleep Disorders Questionnaire which evaluates the risk of primary sleep disorders according to the International Classification of Sleep Disorders (ICSD-3), Athens insomnia scale which assesses the risk of insomnia and the STOP-BANG scale, evaluates the risk for sleep apnea; a journal will also be kept noting dreams between the first and second visit.
- •History of cancer or active cancer.
- •Disorders of the nervous system (e.g. epilepsy, migraine).
- •Mental disorders (e.g. depression, bipolar disorder, schizophrenia).
- •Active infection during the study. (Medical history, body temperature measurement and physical examination)
- •Consuming within 12 hours preceding the sleep examination: coffee, caffeinated teas or other beverages containing caffeine, caffeine, or other stimulants.
- •Consuming alcohol on the day of the examination.
- •Pregnancy and lactation (based on the patient's own declaration, pregnancy test is not planned prior to the examination).
- •Any contraindications to participate in the examination in the Investigator's opinion.
研究组 & 干预措施
A: 3rd night with acoustic stimulation
Arm A: PSG (3 nights) with Nightly App - acoustic stimulation during the 3rd night.
干预措施: Nightly App (Device)
B: 2nd night with acoustic stimulation
Arm B: PSG (3 nights) with Nightly App - acoustic stimulation during the 2nd night.
干预措施: Nightly App (Device)
结局指标
主要结局
The ICC for distribution of the total duration of standby periods during phases NREM and REM
时间窗: Through study completion - after 3rd night of PSG
The ICC for distribution of the total duration of standby periods during phases NREM and REM should not be less than 0.6 in the comparative analysis of results provided by the Nightly application and at least one of the visual recordings from polysomnography.
次要结局
- Evaluate the effect of acoustic stimulation - wake after sleep onset(Through study completion - after 3rd night of PSG)
- Evaluate the effect of acoustic stimulation - total sleep time(Through study completion - after 3rd night of PSG)
- Evaluate the effect of acoustic stimulation - sleep latency(Through study completion - after 3rd night of PSG)
- The incidence of arousal and wakening's(Through study completion - after 3rd night of PSG)
- The ICC value when evaluating the accuracy of recognizing sleep phases and vigilance using the Nightly application(Through study completion - after 3rd night of PSG)