Metanephrines in Obstructive Sleep Apnoea

NCT ID: NCT05053685

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

81 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-29

Study Completion Date

2023-08-29

Brief Summary

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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

Detailed Description

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Conditions

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Pheochromocytoma Obstructive Sleep Apnea Catecholamine; Secretion

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Obstructive Sleep Apnoea (OSA)

Subjects with OSA

Measurement of Urine and plasma metanephrines

Intervention Type DIAGNOSTIC_TEST

Measurement of Urine and plasma metanephrines

Elevated Urine Metanephrines

Subjects with elevated metanephrines

Measurement of Urine and plasma metanephrines

Intervention Type DIAGNOSTIC_TEST

Measurement of Urine and plasma metanephrines

Interventions

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Measurement of Urine and plasma metanephrines

Measurement of Urine and plasma metanephrines

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changi General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Changi General Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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OSA_Mets

Identifier Type: -

Identifier Source: org_study_id

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