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临床试验/NCT03575143
NCT03575143已完成不适用

Obstructive Sleep Apnea Endotypes and Impact on Phenotypes of People Living With HIV

University of California, San Diego1 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2018年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
132
试验地点
1
主要终点
Reaction Time Measured Using the Psychomotor Vigilance Task

研究概览

简要总结

The investigators seek to understand how the different underlying causes of OSA affect the way people living with HIV (PLWH) experience OSA. The investigators also want to understand how symptoms of obstructive sleep apnea improve with treatment, and if this too, is affected by the underlying cause of OSA in that individual

详细描述

Overnight Visit #1. Subjects will arrive to the research sleep laboratory at approximately 7PM and undergo the following procedures:

  1. Polysomnography: Monitoring for standard clinical polysomnography study will be applied to the subject, as follows: The subject will have EEG, EMG, EOG, and ECG electrodes, an adhesive body position sensor placed in standard locations. Pulse oximetry sensor will be attached either to a finger or ear lobe and secured by tape. The following parameters will be measured during sleep: electroencephalogram, eye movement, electrocardiogram, electromyogram, leg movement, snoring sounds, nasal pressure, and nasal-oral airflow by thermistor, respiratory effort and body position by piezo-electric bands of the thorax and abdomen or magnetometers, position sensors, and pulse oximetry. This equipment is standard for diagnostic polysomnography and should not be uncomfortable.

Once all of this equipment has been comfortably and securely fastened, the subject will be allowed to fall asleep and data recording will begin. Subjects will be asked to remain in the supine position as much as possible. All data will be acquired on a 1401 plus interface and Spike 2 software. The study will end at approximately 6 AM, at which time the monitoring equipment will be removed, and the subject will undergo a blood draw in this fasting state. 2. Phlebotomy: Venipuncture will be performed by a certified research staff or physician using standard techniques and appropriate blood borne pathogen precautions. Approximately 10-15 cc of blood will be drawn in the morning at wake into serum separator and EDTA tubes. Serum samples will be immediately processed to separate serum, which will be stored in darkness at -70 F to preserve until analysis can be conducted. EDTA tubes will be processed and refrigerated for use within 24 hours. Blood will also be collected to measure high sensitivity C Reactive Protein (hsCRP), insulin, glucose (to calculate HOMA-IR), cytokines such as IL-6 and TNF-alpha.119 The investigators will also store plasma for other potential markers, to explore other interactions, such as markers of liver disease like ALT and AST.

Subjects will then be able to go home. They will leave the actiwatch for the investigators. The investigators anticipate that Overnight Visit #1 will last 10 hours (most of which will be spent asleep).

If subjects are not found to have OSA, they will not continue with the study. (End of Aim #1)

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

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

入选标准

  • Physician diagnosis of HIV and viral suppression
  • Ages 18-65 years old
  • BMI 20 - 35 kg/m2

排除标准

  • Pregnancy
  • Inability to complete study procedures, such as questionnaires that are only available/validated in English.
  • Known OSA already on effective therapy and adherent to treatment
  • Other known untreated sleep fragmenting disorder, such as periodic limb movement disorder, or narcolepsy. We will NOT exclude based on insomnia, given that OSA and insomnia frequently exist together.
  • Chronic lung disease requiring the use of supplemental oxygen, or with evidence of hypercapnia due to obstructive lung disease.

结局指标

主要结局

Reaction Time Measured Using the Psychomotor Vigilance Task

时间窗: 1 day

The Psychomotor Vigilance Task (PVT) is commonly used to asses the impact of sleep (or sleep deprivation) on cognitive performance. Subjects are instructed to respond (by tapping a key on a keyboard) as fast as possible to a graphical stimulus displayed on a computer screen. The stimulus is presented multiple times at variable intervals every few seconds for 10 minutes. The reaction time is the mean latency from appearance of the stimulus to the response by the participant. Higher values suggest a slower reaction time compared to lower values.

次要结局

  • Reactive Hyperemia Index (RHI) Assessed by Peripheral Arterial Tonometry(1 day)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert L. Owens

Associate Clinical Professor

University of California, San Diego

研究点 (1)

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