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临床试验/NCT04358796
NCT04358796已完成不适用

Measuring Cognitive Enhancement During Hyperbaric Oxygen Treatments

Assaf-Harofeh Medical Center2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年11月10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
69
试验地点
2
主要终点
Information processing speed

研究概览

简要总结

The aim of the current study was to examine the effect of short-term HBOT (hyperbaric oxygen treatments) on a range of cognitive abilities. The current study examined whether there is a HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities are improved by the intervention.

Participants were randomized to perform cognitive tasks in one of two chambers with two different clinical environments: (a) HBOT condition: (2 ATA (atmosphere absolute) 100% oxygen for 90 minutes). (b) Control condition: in which the chamber was not pressurized (Normobaric condition- 1 ATA for 90 minutes).

详细描述

The aim of the current study was to examine the effect of short-term HBOT on a range of cognitive abilities. The current study examined whether there is a HBOT-related short-term cognitive improvement and, if so, what specific cognitive abilities are improved by the intervention.

Participants were recruited through ads on the internet and on student social groups. All participants underwent a comprehensive physical and neurological examination, and general medical conditions were ruled out. Participants were excluded if reported changes in their cognitive or behavioral functions during one month prior to the beginning of the study. Smokers (people who smoke more than seven cigarettes a week) were required to take a lung x-ray confirming there isn't a pulmonary pathology, such as pneumothorax, pulmonary bullae, emphysema, or other lung pathologies preventing them from staying in a high ATA environment. Participants with an abnormal x-ray were excluded from the study. Participants who regularly use Methylphenidate (i.e. Ritalin) or other stimulants for attention disorders (i.e. ADHD) were instructed not to take it at the day of the experiment.

Following consent, all the participants were exposed to the testing battery in a group setting. One of the experimenters went through each of the sub-tests instructions in a detailed manner prior to a practice phase in which participants trained on the tasks. Afterwards, participants were randomized to perform the tasks in one of two chambers with two different clinical environments: (a) HBOT condition: (2 ATA 100% oxygen for 90 minutes). The atmospheric pressure in this condition was set to 2 ATA. This ATA level is known to have a clinical effect, whereas higher-pressure levels may result in inhibitory brain effects or even lead to focal toxicity (Efrati and Ben-Jacob, 2014). (b) Control condition: in which the chamber was not pressurized (Normobaric condition- 1 ATA for 90 minutes) and participants breathed air (21% oxygen). In this condition, ATA was elevated for a few minutes to 1.2 ATA in order to mimic the feeling of pressure building up in the ears. The pressure was decreased soon after to 1 ATA.

The assessment began 30 min after participants wore the oxygen masks within the chamber, in order to enable appropriate brain oxygenation in the HBOT condition (Vadas et al., 2017). The battery was composed of cognitive tests adapted for high functioning subjects and adjusted to an in-chamber group administration setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

Patients are unaware to the ATA in chamber and to oxygen levels in their mask.

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 20-40
  • intact sight / corrected sight
  • Hebrew as mother tongue
  • Intact comprehension

排除标准

  • Active neurologic or psychiatric diagnosis.
  • If Had been treated with HBOT for any other reason prior to their inclusion;
  • Chest pathology ;
  • Inner ear disease;
  • Claustrophobia;

结局指标

主要结局

Information processing speed

时间窗: after 20 minutes of intervention

Accuracy rates on an information processing speed task (Symbol tracing task)

Response inhibition

时间窗: after 20 minutes of intervention

Accuracy rates on a response inhibition task (stroop)

Problem solving

时间窗: after 20 minutes of intervention

accuracy rates on a problem solving task (solving arithmetic series)

Divided attention

时间窗: after 20 minutes of intervention

accuracy rates on a divided attention task (identifying visual and auditory targets)

memory

时间窗: after 20 minutes of intervention

Number of words retrieved from a list

Working memory

时间窗: after 20 minutes of intervention

accuracy rates on a working memory paradigm (n-back)

次要结局

未报告次要终点

研究者

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

Prof. Shay Efrati

Medical Director of the Sagol Center for Hyperbaric Medicine

Assaf-Harofeh Medical Center

研究点 (2)

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