Feasibility of providing additional oxygen in patients with resistant high blood pressure and obstructive sleep apnoea
- Conditions
- Obstructive sleep apnoea in patients with difficult-to-treat hypertensionSleep apnoeaNervous System Diseases
- Registration Number
- ISRCTN51046126
- Lead Sponsor
- niversity of Oxford
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 20
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
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. % of participants with an Apnoea–Hypopnoea Index (AHI) >15, measured by home polygraphy at screening<br>2. % of participants using supplemental oxygen for an average of =6 hours/night measured by self report at 2 week follow up
- Secondary Outcome Measures
Name Time Method 1. Sleep apnoea related quality of life measured using Sleep Apnoea related Quality of Life Index (SAQLI) at baseline and 2 week follow-up visit<br>2. Overnight oxygen levels measured by oxygen desaturation index at screening polygraphy and night 14 oximetry<br>3. Blood pressure (sphygmomanometer) on days -2, -1 and 0, and Days 12, 13, 14<br>4. Carbon dioxide and base excess levels measured using average capillary PCO2 and base excess with supplemental oxygen at baseline and 2 week follow-up visit