Metanephrines in Obstructive Sleep Apnoea

Obstructive Sleep Apnea Clinical Trial

Official title:

Utility of Plasma and Urine Metanephrines in the Diagnosis of Phaeochromocytoma in Patients With Obstructive Sleep Apnoea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05053685
• Other study ID #: OSA_Mets
• Status: Recruiting
• Start date: July 29, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2021
• Source: Changi General Hospital
• Contact: Thomas King, MD
• Phone: +6569365651
• Email: thomas.king[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2021
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients aged 21-70 years attending for a sleep study to evaluate for OSA

Exclusion Criteria:

• Medications that can cause changes in metanephrine levels

• Other factors that can cause changes in metanephrine levels

• Renal impairment (eGFR < 60ml/min)

• Other serious medical conditions

Related Conditions & MeSH terms

• Apnea
• Catecholamine; Secretion
• Obstructive Sleep Apnea
• Pheochromocytoma
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Diagnostic Test:
• Measurement of Urine and plasma metanephrines
Measurement of Urine and plasma metanephrines

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urine and plasma metanephrines	Measurement of 24 hours urine metanephrines	1 year
Primary	Urine and plasma metanephrines	Measurement of plasma metanephrines	1 year
Secondary	Relationship between metanephrine level and severity of OSA	comparison of metanephrine level and severity of OSA as dertermined by sleep study	1 year
Secondary	Change in metanephrine levels with treatment for OSA	Change in plasma and urine metanephrine levels during treatment for OSA	1 year