The feasibility of supplemental oxygen in patients with resistant hypertension and obstructive sleep apnoea
Obstructive sleep apnoea in patients with difficult-to-treat hypertension
Current interventions as of 04/04/2023: This is a single-arm, non-blinded study to assess the feasibility of screening for obstructive sleep apnoea in patients with difficult-to-treat hypertension and to assess the feasibility, tolerability and safety of oxygen in patients with uncontrolled high blood pressure and OSA. Oxygen has not been tested in this way and this feasibility data is needed to see if this is an acceptable treatment for patients. This will provide useful information as to the promise of using oxygen as a treatment for OSA. The study is divided into two stages, with Stage 1 identifying the prevalence of OSA in patients with resistant hypertension in a tertiary hypertension clinic, and Stage 2 assessing the feasibility of supplemental oxygen in participants with resistant hypertension who were identified to have OSA in Stage 1. Participants will have a total of four research appointments. This will consist of two virtual screening visits, conducted either by video conference or telephone and this will be followed by two face-to-face visits; a baseline and a follow-up visit. Patients can expect to be in the study for a minimum of 15 days to a maximum of 15 weeks from home polygraphy. Further study details are listed below. If face-to-face appointments are not possible (due to site guidance in response to an increase in COVID-19 cases), Stage 2 will be carried out virtually with two virtual visits instead of two face-to-face visits. As this is a feasibility study, no formal power calculation has taken place. We aim to enrol 20 patients which allow for screening failures and drop-outs should allow 6 patients to receive oxygen for 14 days. This will provide data screening prevalence of OSA, oxygen usage and safety data. This study is planned to complete recruitment and follow-up within 1 year. There are no planned interim analyses. Previous interventions: This is a single arm, non-blinded study to assess the feasibility of screening for obstructi
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)