Metanephrines in Obstructive Sleep Apnoea

NCT05053685 | Completed

• 1 other identifier: OSA_Mets
• Study Type: observational
• Target: 81
• Locations: 1 country
• Sites: 1

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

Conditions

Pheochromocytoma; Obstructive Sleep Apnea; Catecholamine; Secretion

Outcome Measures

Primary Outcomes (2)

• Urine and plasma metanephrines

  Measurement of 24 hours urine metanephrines

  1 year

• Urine and plasma metanephrines

  Measurement of plasma metanephrines

  1 year

Secondary Outcomes (2)

• Relationship between metanephrine level and severity of OSA

  1 year

• Change in metanephrine levels with treatment for OSA

  1 year

Study Arms (2)

Obstructive Sleep Apnoea (OSA)

Subjects with OSA

Diagnostic Test: Measurement of Urine and plasma metanephrines

Elevated Urine Metanephrines

Subjects with elevated metanephrines

Diagnostic Test: Measurement of Urine and plasma metanephrines

Interventions

Measurement of Urine and plasma metanephrines DIAGNOSTIC_TEST

Measurement of Urine and plasma metanephrines

Elevated Urine Metanephrines; Obstructive Sleep Apnoea (OSA)

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients attending for sleep studies for evaluation of OSA

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Pheochromocytoma; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Paraganglioma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 22, 2021
• Study Start: July 29, 2020
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: August 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)