ISRCTN51046126进行中（未招募）未知
The feasibility of supplemental oxygen in patients with resistant hypertension and obstructive sleep apnoea
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 入组人数
- 20
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
- •Current participant inclusion criteria as of 04/04/2023:
- •1. Participant is willing and able to give informed consent for participation in the trial
- •2. Male or Female, aged 18 years or above
- •3. Current diagnosis (at time of enrolment) of hypertension
- •4. Ambulatory blood pressure monitoring showing either systolic >135mmHg or diastolic >85mmHg on ambulatory blood pressure monitoring following observed administration of medications
- •5. Using one or more current regular anti-hypertensive medications for at least 4 weeks before trial entry
- •6. In the Investigator’s opinion, is able and willing to comply with all trial requirements
- •7. Participant has access to a home computer and/or other device connected to the internet and an email account
- •Previous participant inclusion criteria:
- •1. Participant is willing and able to give informed consent for participation in the trial
- •2. Male or Female, aged 18 years or above
- •3. Current diagnosis (at time of enrolment) of resistant hypertension
- •4. Ambulatory blood pressure monitoring showing either systolic >145mmHg or diastolic >85mmHg on ambulatory blood pressure monitoring following observed administration of medications
- •5. Stable dose of three or more current regular anti-hypertensive medication for at least 4 weeks prior to trial entry
- •6. In the Investigator’s opinion, is able and willing to comply with all trial requirements.
- •7. Participant has access to home computer and/or other device connected to the internet and an email account
排除标准
- •1. Significant renal or hepatic impairment
- •2. Scheduled elective surgery or other procedures requiring general anaesthesia during the trial
- •3. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
- •4. Participants who have participated in another research trial involving an investigational product in the past 12 weeks
- •5. Secondary causes of hypertension (other than OSA)
- •6. Excessive sleepiness with an ESS >16 (as assessed clinically prior to enrolment) or a history of sleepiness-related driving related accident
- •7. Professional drivers or vigilance critical occupation
- •8. Any prior use of CPAP
- •9. Current smoker or other cause of increased fire risk with oxygen therapy (i.e. relative smoking in the participant's residence)
- •10. An AHI of <=15 on both nights of screening polygraphy
- •11. Baseline capillary blood gas PCO2 > 6.5kPa, or if unavailable, awake saturations < 93% on overnight polygraphy (assessed at the face to face Baseline visit prior to proceeding with the visit)
研究者
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