Ignite Creation Date:
2024-05-06 @ 4:41 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05053685
Status:
COMPLETED
Last Update Posted:
2021-09-22
First Post:
2021-09-12
Brief Title:
Metanephrines in Obstructive Sleep Apnoea
Sponsor:
Changi General Hospital
Organization:
Changi General Hospital
Study Overview
Official Title:
Utility of Plasma and Urine Metanephrines in the Diagnosis of Phaeochromocytoma in Patients With Obstructive Sleep Apnoea
Status:
COMPLETED
Status Verified Date:
2023-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Although most patients have essential unexplained hypertension some patients have a treatable underlying condition One such condition is phaeochromocytoma a tumour that produces excessive stress hormones Left undiagnosed patients may develop a hypertensive crisis that can be fatal Measurements of stress hormones both 24-hour urine collection and morning blood tests are highly sensitive for detecting these tumours However these stress hormones may also be elevated in obstructive sleep apnoea OSA which affects 1 in 5 adults
The investigators hypothesize that in patients with OSA blood tests will be better than 24-hr urine tests at ruling out a tumour If this is confirmed then OSA patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test reducing unnecessary additional tests and patient anxiety
In this single site study the investigators plan to recruit 70 patients undergoing polysomnography 24hr urine and bloods will be measured Patients with elevated hormone levels will undergo imaging to rule out a tumour
The primary outcome will be the accuracy of each test in ruling out a tumour The secondary outcomes will be the relationship between stress hormone level and severity of OSA which may help to explain the increased cardiovascular risk in patients with OSA and the change in stress hormone level with treatment for OSA
The investigators hypothesize that in patients with OSA blood tests will be better than 24-hr urine tests at ruling out a tumour If this is confirmed then OSA patients with suspected phaeochromocytoma could be investigated with a morning blood test instead of a traditional urine test reducing unnecessary additional tests and patient anxiety
In this single site study the investigators plan to recruit 70 patients undergoing polysomnography 24hr urine and bloods will be measured Patients with elevated hormone levels will undergo imaging to rule out a tumour
The primary outcome will be the accuracy of each test in ruling out a tumour The secondary outcomes will be the relationship between stress hormone level and severity of OSA which may help to explain the increased cardiovascular risk in patients with OSA and the change in stress hormone level with treatment for OSA
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None