Ocular Parameters Assessment With a Deep Neural Network in Patients With Sleep Apnea
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of complete blinks for each minute
研究概览
简要总结
The aim of this study is to assess the ocular parameters of drowsiness in patients with diagnosed Obstructive Sleep Apnea Syndrome through objective methods of ocular imaging and subjective evaluation methods (questionnaire)
详细描述
This is a single-center prospective comparative observational study. One hundred patients with drowsiness that will be examined in the Sleep Clinic of Alexandroupolis University Hospital, aged between18-70 years old, with Distance Uncorrected Visual Acuity ≥ (dUVA): 5/10 will be recruited. They will be separated into two groups, one consisting of patients with diagnosed Obstructive Sleep Apnea and one without this diagnosis, according to the Epworth Sleepiness Scale - ESS, which is a valid tool for quantifying daily sleepiness. A 10-minute video in a foreign language (not English or Greek) with greek subtitles will be presented to them and a questionnaire will follow to assess the level of concentration during the video (the subtitles are crucial to understanding the video's plot). The video will be displayed in a 11.6" screen with resolution of 1920x1080 pixels, at 70 cm patient-to-screen distance. The patients' eyes will be recorded during the video with a Raspberry Pi Camera Module IR-CUT v2 (5MP,1080p) with 2 IR LED lights, connected to a Raspberry Pi 3 model v1.2, operating at the original resolution of 1080×1920, at 20 cm patient-to-camera distance and an algorithm will be developed to analyze the following parameters: 1. The complete and incomplete blinks defined by the "length of palpebral fissure-to-iris diameter" ratio, 3. Length of palpebral fissure of both eyes.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with obstructive sleep apnea and controls, aged 18-70 years old, with distance uncorrected visual acuity (dUVA) ≥ 5/10.
排除标准
- •(dUVA) <5/10,
- •intraocular pressure lowering medications
- •former corneal or fundus disease
- •neurological or psychiatric conditions
- •mental disability
- •difficulty reading
结局指标
主要结局
Number of complete blinks for each minute
时间窗: 1 week
Number of complete blinks for each minute of the 10-minute video
Length of palpebral fissure of both eyes
时间窗: 1 week
The distance between the upper eyelid margin and the lower eyelid margin (ie. the vertical dimension of the palpebral fissure) for each frame
Total number of complete blinks during the 10-minute video
时间窗: 1 week
The total number of complete blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Number of total blinks for each minute
时间窗: 1 week
Number of total blinks for each minute of the 10-minute video
Total blinks per minute
时间窗: 1 week
Total blinks per minute during the 10-minute video
Complete blinks per minute
时间窗: 1 week
Complete blinks per minute during the 10-minute video
Total number of incomplete blinks during the 10-minute video
时间窗: 1 week
The total number of incomplete blinks during the 10-minute video. Incomplete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Incomplete blinks per minute
时间窗: 1 week
Incomplete blinks per minute during the 10-minute video
Total number of blinks during the 10-minute video
时间窗: 1 week
The total number of blinks during the 10-minute video. Complete blinks are defined by the "length of palpebral fissure-to-iris diameter" ratio.
Number of incomplete blinks for each minute
时间窗: 1 week
Number of incomplete blinks per minute for each minute of the 10-minute video
次要结局
- Fixation duration(1 week)
- Reading time(1 week)
- Fixations to the area of interest(1 week)
- Participant's dedication time to the area of focus(1 week)
- Rereadings(1 week)
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace