The Face of Sleepiness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Photographic assessment of changes in facial indicators of sleepiness (ptosis, flattening or darkening of the external infraorbital surface) after PAP-treatment
研究概览
简要总结
The purpose of this pilot study is to find out whether successful treatment of obstructive sleep apnea makes people look less sleepy, for example by reducing swelling or dark circles under the eyes. In addition, this study will help determine whether facial photographs may be used to help identify patients who should be tested for sleep apnea and daytime sleepiness.
详细描述
The main symptom of nocturnal sleep disorders is often excessive daytime sleepiness. Although sleepiness can be a major contributor to decreased quality of life, and even mortality, patients frequently grow habituated to their sleepiness, ignoring it and any underlying disorder. One scarcely explored potential consequence that could motivate patients to address sleep disorders is a sleepy facial appearance. No peer-reviewed literature, to our knowledge, has explored whether inadequate or insufficient sleep actually causes changes facial appearance. No published literature has examined the extent to which treatment for sleep disorders might improve such facial changes, and perhaps motivate patients to treat their sleep disorders.
To address these questions in a preliminary manner, therefore, the investigators propose to use cutting-edge photographic technology to assess subtle changes in facial appearance. The investigators will recruit 20 sleepy adult patients who are diagnosed with obstructive sleep apnea, an ideal disease model in which subjects can be tested before and after alleviation of severe sleepiness by home use of continuous positive airway pressure. Results of this pilot study could show for the first time that successful treatment of a chronic sleep disorder improves facial features commonly perceived as an undesirable sign of sleepiness.
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
- •Adults, age 18-65
- •Recently diagnosed with obstructive sleep apnea, confirmed by polysomnography (sleep study)
- •Experiencing daytime sleepiness, based on Epworth Sleepiness Scale
- •Scheduled for a positive airway pressure (PAP) titration study (CPAP or BiPAP)
- •Willing to use CPAP or BiPAP at pressures prescribed by the treating physician
- •Willing to have facial photographs taken before treatment and 2-4 months after nightly use of CPAP or BiPAP
排除标准
- •Diagnosed with other sleep, medical or psychiatric disorders that might limit the effectiveness of PAP treatment (such as morbid obesity, emphysema, and neurodegenerative disorders)
- •Conditions that may cause daytime sleepiness (such as narcolepsy, primary insomnia, seizure disorders, or major depression)
- •Use of medications or herbal remedies that affect sleep and behavior
- •History of facial plastic or reconstructive surgery or Botox injections or plans to undergo these types of treatments prior to completing the second study visit
结局指标
主要结局
Photographic assessment of changes in facial indicators of sleepiness (ptosis, flattening or darkening of the external infraorbital surface) after PAP-treatment
时间窗: 2-4 months after successful nightly use of CPAP or BiPAP
次要结局
- Blinded raters provide visual assessment of relative improvement in facial images of subjects after successful PAP treatment(2-4 months after successful nightly use of CPAP or BiPAP)
研究者
Ronald D. Chervin, M.D., M.S.
Professor of Neurology and Michael S Aldrich Sleep Collegiate Professor of Sleep Medicine
University of Michigan