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OpenTrials
Completed

NCT Number: NCT05053685

Metanephrines in 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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Measurement of Urine and plasma metanephrines

Diagnostic Test

Measurement of Urine and plasma metanephrines

Primary outcomes

  1. Urine and plasma metanephrines

    Time frame: 1 year

    Measurement of 24 hours urine metanephrines

  2. Urine and plasma metanephrines

    Time frame: 1 year

    Measurement of plasma metanephrines

Secondary outcomes

  1. Relationship between metanephrine level and severity of OSA

    Time frame: 1 year

    comparison of metanephrine level and severity of OSA as dertermined by sleep study

  2. Change in metanephrine levels with treatment for OSA

    Time frame: 1 year

    Change in plasma and urine metanephrine levels during treatment for OSA

Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 22, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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