AcromegalyNCT02371057
Acromegaly & Sleep Apnoea
An observational study of Acromegaly, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
Trial summary
Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acromegaly
- How many people
- 653 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Nov 2014to 21 Feb 2018
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients attending the sleep apnoea clinic.
Who may be able to join
- Adults aged 16 and above.
- Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea
- Have capacity to given informed consent.
Who cannot join
- Patients under 16 years of age
- Not referred to the Sleep Apnoea Clinic
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust
Leeds, West Yorkshire, LS9 7TF
About this study
Official title: The Prevalence of Acromegaly in the Sleep Apnoea Clinic
Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.
Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.
The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.
- Conditions
- Acromegaly
- Medical subject headings
- Acromegaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients under follow-up known to have sleep apnoea | Not described | |
| patients attending the sleep apnoea clinic for assessment | Patients who are attending clinic who have not yet been diagnosed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of acromegaly within patients referred to the sleep apnoea clinic.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study start24 Nov 2014
- Primary completion21 Feb 2018
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcromegalyStudies 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
- 653 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Leeds Teaching Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371057
- Sponsor's protocol ID
- ED13/10973
- Status last verified
- Aug 2019
- First submitted
- 11 Feb 2015
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Acromegaly in the Sleep Apnoea Clinic
- ClinicalTrials.gov ID
- NCT02371057
- Acronym / sponsor ID
- ED13/10973
- Conditions
- Acromegaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 653 participants (actual)
- Lead sponsor
- The Leeds Teaching Hospitals NHS TrustUniversity, hospital or other
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 21 Feb 2018 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 25 Feb 2015 (estimated)
- 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.
Estimates of the prevalence of acromegaly, a condition resulting from excess growth hormone secretion, are as high as 1:1000. If detected late acromegaly increases the risk of joint destruction, heart disease, sleep apnoea, high blood pressure, diabetes, and polyps in the colon. To have a greater effect on long-term outcomes this disease needs to be detected early. By screening a 'high risk' population (sleep apnoea clinic) the investigators may be able to detect these patients earlier and prevent late complications of the disease. At LTHT the referral pathway for new referrals to the sleep apnoea clinic involves initial attendance to pick up a pulse oximeter to wear overnight to measure oxygen levels. These readings show approximately 1:4 patients displays evidence of significant obstructive sleep apnoea to warrant referral to the treatment group for continuous positive airway pressure (CPAP), weight management, and occasionally mandibular adjustment.
Patients attending the sleep apnoea clinic either as new referral or for review will be asked to participate in the proposed study. The study is cross-sectional in design incorporating two sub-populations within the sleep apnoea clinic. The first cohort comprises patients under follow-up known to have sleep apnoea, and the second cohort those patients prospectively attending the sleep apnoea clinic for assessment. If after an explanation of the study they agree to participate blood will be taken for assessment of IGF-I and they will be asked to complete a simple questionnaire.
The aim will to be to screen 1000 consecutive patients. The questionnaire will incorporate five simple questions to be completed with a 'yes' or 'no' answer. Where IGF-I levels are elevated patients will be investigated further for the possibility of acromegaly. The presence of biochemically proven acromegaly will be used to determine if the simple question has sufficient sensitivity to use as a screening tool.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients under follow-up known to have sleep apnoea | – | – |
| patients attending the sleep apnoea clinic for assessment | – | –Patients who are attending clinic who have not yet been diagnosed. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attending the sleep apnoea clinic.
Key inclusion criteria (3 listed)
- Adults aged 16 and above.
- Referred to the Sleep Apnoea Clinic for assessment of obstructive sleep apnoea
- Have capacity to given informed consent.
Key exclusion criteria (3 listed)
- Patients under 16 years of age
- Not referred to the Sleep Apnoea Clinic
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The prevalence of acromegaly within patients referred to the sleep apnoea clinic.
Time frame: 2 years
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 19 Aug 2019.
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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 Acromegaly, run by The Leeds Teaching Hospitals NHS Trust at 1 site in United Kingdom.
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 3 inclusion and 3 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 19 Aug 2019. 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 United Kingdom. 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?
The prevalence of acromegaly within patients referred to the sleep apnoea clinic. (time frame: 2 years). 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 19 Aug 2019.