Metanephrines in Obstructive Sleep Apnoea

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

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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea; Pheochromocytoma; Catecholamine; Secretion
• Intervention / Treatment: Diagnostic test: Measurement of Urine and plasma metanephrines

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Thomas King, MD; Phone Number: +6569365651; Email: thomas.king@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 529889
    • Recruiting
    • Changi General Hospital
    • Contact: Thomas King, MD; Phone Number: +6569365651; Email: thomas.king@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients attending for sleep studies for evaluation of OSA

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Obstructive Sleep Apnoea (OSA); Subjects with OSA	Diagnostic test: Measurement of Urine and plasma metanephrines; Measurement of Urine and plasma metanephrines
Elevated Urine Metanephrines; Subjects with elevated metanephrines	Diagnostic test: Measurement of Urine and plasma metanephrines; Measurement of Urine and plasma metanephrines

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine and plasma metanephrines	Measurement of 24 hours urine metanephrines	1 year
Urine and plasma metanephrines	Measurement of plasma metanephrines	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relationship between metanephrine level and severity of OSA	comparison of metanephrine level and severity of OSA as dertermined by sleep study	1 year
Change in metanephrine levels with treatment for OSA	Change in plasma and urine metanephrine levels during treatment for OSA	1 year

Collaborators and Investigators

• Sponsor: Changi General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2020
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: September 12, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 22, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2021
• Last Update Submitted That Met QC Criteria: September 14, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Signs and Symptoms, Respiratory; Neuroendocrine Tumors; Paraganglioma; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Apnea; Pheochromocytoma
• Other Study ID Numbers: OSA_Mets

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No