ISRCTN76074900已完成未知
Rapid circadian re-Entrainment to modify Sleep parameters upon acute hypoxic Exposure after jeT lag (RESET): a randomised crossover trial
niversity of Edinburgh0 个研究点目标入组 35 人开始时间: 2021年11月24日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 35
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Accepted as members of the APEX 6 expedition (aged 18-25 years; there is no obligation to take part in the research having been accepted on the expedition).
- •2. Able to provide details of registration at a GP surgery.
- •3. In the case of volunteers who regularly attend a medical clinic, confirmation that they have informed the hospital specialist that they intend to participate in the expedition.
- •4. Identify themselves as being healthy.
- •5. Capacity to understand written and verbal information provided in English, and able to provide valid written informed consent to participate.
排除标准
- •1. Previous admission to hospital with acute asthma
- •2. Significant cardio-respiratory disease
- •3. Regular cardiovascular medications
- •4. Advised against travel to altitude by GP, relevant hospital specialist, or APEX6 expedition doctors
- •5. Positive COVID-19 test within 14 days prior to departure
- •6. COVID-19 symptoms within 14 days prior to departure, without negative COVID-19 test
- •7. Pregnancy/possible pregnancy
- •8. Smoking
- •The following ‘absolute research’ exclusion criteria will prevent participants taking part in all research elements on the APEX 6 expedition (including the RESET trial), but will not prevent them from joining the APEX 6 expedition:
- •9. Subjects who have been exposed to altitude above 2500m in the two months preceding the expedition.
- •10. Subjects who take acetazolamide (Diamox) during the expedition
- •11. Subjects who consume alcohol or South American herbal-based remedies for AMS (coca-leaf tea/mate de coca) on research sampling days
- •The following ‘specific’ exclusion criteria will prevent participants taking part in the observational ‘Hypoxia and body clocks’ research element of APEX 6 and the RESET trial, but will not prevent them from taking part in other research elements on APEX 6:
- •12. Subjects who carry out night shift work in the week before the expedition, have a clinically diagnosed sleep disorder, or who do not fly to South America from Europe and back again for the expedition.
- •The following ‘specific’ exclusion criteria relate only to the RESET trial:
- •13. Subjects with a history of gastric ulceration, diabetes mellitus, or that take systemic steroid-based medications in the month before the expedition will be excluded from the trial in its entirety.
- •14. Any subject with a body weight of <80 pounds, gastrointestinal disease, history of glaucoma, gastric cancer, previous gastrointestinal surgery/obstruction, epilepsy, liver disease, heart disease, renal disease, signs/history of impaired gag reflex, previous adverse reaction to either dexamethasone or omeprazole, current infection or pre-existing immunocompromise will be excluded from the pharmaceutical aspect of the intervention and the CorTemp™ element of the trial.
- •15. Participants that require any prescription or non-prescription medications (with the exception of paracetamol, hormone-based contraceptives, fluoxetine, sertraline, trazodone, codeine and gabapentin; updated 07/05/2022: antihistamines, tetracycline antibiotics, isotretinoin, vitamin or
- •mineral supplements, locally administered steroids [including topical creams, inhalers, and nasal sprays]) during their allocated 3-day intervention period will be excluded from the medicinal aspect of the intervention only (dexamethasone and omeprazole).
- •16. Any subject with a body weight of <80 pounds, gastrointestinal disease, history of gastric cancer, previous gastrointestinal surgery/obstruction, signs/history of impaired gag reflex, will be excluded from the CorTemp™ component only.
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