Obstructive sleep apnoea in patients with difficult-to-treat hypertension Nervous System Diseases Sleep apnoea
Conditions
Interventions
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
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-fac
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. % of participants with an Apnoea–Hypopnoea Index (AHI) >15, measured by home polygraphy at screening 2. % of participants using supplemental oxygen for an average of =6 hours/night measured by self report at 2 week follow up | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 2. Overnight oxygen levels measured by oxygen desaturation index at screening polygraphy and night 14 oximetry 3. Blood pressure (sphygmomanometer) on days -2, -1 and 0, and Days 12, 13, 14 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 | — |
Countries
England, United Kingdom
Outcome results
None listed