PheochromocytomaNCT05053685
Metanephrines in Obstructive Sleep Apnoea
An observational study of Pheochromocytoma and Obstructive Sleep Apnea, run by Changi General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pheochromocytoma, Obstructive Sleep Apnea, Catecholamine; Secretion
- What is being tested?
- Measurement of Urine and plasma metanephrines
- How many people
- 81 participants
- Where
- 1 siteSingapore
- Study dates
- 29 Jul 2020to 29 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients attending for sleep studies for evaluation of OSA
Who may be able to join
- Patients aged 21-70 years attending for a sleep study to evaluate for OSA
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Being tested
- Measurement of Urine and plasma metanephrines
- Medical subject headings
- Pheochromocytoma, Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of Urine and plasma metanephrinesDiagnostic test
Measurement of Urine and plasma metanephrines
| Study group | Role | What they receive |
|---|---|---|
| Obstructive Sleep Apnoea (OSA) | Subjects with OSA Receives: Diagnostic Test: Measurement of Urine and plasma metanephrines | |
| Elevated Urine Metanephrines | Subjects with elevated metanephrines Receives: Diagnostic Test: Measurement of Urine and plasma metanephrines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine and plasma metanephrines
Measurement of 24 hours urine metanephrines
Measured: 1 year
Urine and plasma metanephrines
Measurement of plasma metanephrines
Measured: 1 year
Secondary outcomes (2)
Relationship between metanephrine level and severity of OSA
comparison of metanephrine level and severity of OSA as dertermined by sleep study
Measured: 1 year
Change in metanephrine levels with treatment for OSA
Change in plasma and urine metanephrine levels during treatment for OSA
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start29 Jul 2020
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PheochromocytomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053685
- Sponsor's protocol ID
- OSA_Mets
- Status last verified
- Aug 2023
- First submitted
- 12 Sep 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Plasma and Urine Metanephrines in the Diagnosis of Phaeochromocytoma in Patients With Obstructive Sleep Apnoea
- ClinicalTrials.gov ID
- NCT05053685
- Acronym / sponsor ID
- OSA_Mets
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 29 Jul 2020 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnoea (OSA) | – | Diagnostic Test: Measurement of Urine and plasma metanephrinesSubjects with OSA |
| Elevated Urine Metanephrines | – | Diagnostic Test: Measurement of Urine and plasma metanephrinesSubjects with elevated metanephrines |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending for sleep studies for evaluation of OSA
Key inclusion criteria (1 listed)
- Patients aged 21-70 years attending for a sleep study to evaluate for OSA
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of Urine and plasma metanephrinesMeasurement of Urine and plasma metanephrines | Diagnostic test | Elevated Urine Metanephrines, Obstructive Sleep Apnoea (OSA) |
Primary outcome
Urine and plasma metanephrines
Time frame: 1 year
Measurement of 24 hours urine metanephrines
Urine and plasma metanephrines
Time frame: 1 year
Measurement of plasma metanephrines
2 secondary outcomes
Relationship between metanephrine level and severity of OSA
Time frame: 1 year
Change in metanephrine levels with treatment for OSA
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pheochromocytoma and Obstructive Sleep Apnea, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine and plasma metanephrines (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 26 Oct 2026.