Sleep ApneaNCT03526016
Sleep Apnea in Acromegaly After Surgery
An observational study of Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Sleep apnea is common in acromegaly and both diseases are independently associated with hypertension and insulin resistance contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Sleep Apnea
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Feb 2018to Dec 2021
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary referral hospital
Who may be able to join
- patients with newly diagnosed acromegaly
Who cannot join
- patients who can not undergo transsphenoidal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110744
Jinwoo Lee, MD, 82-2-2072-7593, realrain7@gmail.com
About this study
Official title: Effect of Transsphenoidal Surgery on Sleep Apnea in Patients With Acromegaly
Sleep apnea is common in acromegaly and both diseases are independently associated with hypertension and insulin resistance contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea.
The aim of this study is to evaluate the prevalence of sleep apnea by respiratory polygraphy, and to analyze the effect of transsphenoidal surgery on sleep apnea.
- Conditions
- Sleep Apnea
- Keywords
- Sleep Apnea, Acromegaly, Transsphenoidal surgery, Respiratory polygraphy
- Medical subject headings
- Sleep Apnea Syndromes, Acromegaly
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Respiratory disturbance index
Changes in respiratory events during sleep
Measured: Baseline and 3 months after transsphenoidal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start21 Feb 2018
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jinwoo Lee, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03526016
- Sponsor's protocol ID
- 1802032919
- Status last verified
- Aug 2021
- First submitted
- 2 May 2018
- Last updated
- 20 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cho J, Kim JH, Kim YH, Lee J. Obstructive Sleep Apnea Screening and Effects of Surgery in Acromegaly: A Prospective Study. Endocrinol Metab (Seoul). 2024 Aug;39(4):641-652. doi: 10.3803/EnM.2024.1933. Epub 2024 Jun 26.
PubMed 38918903
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Transsphenoidal Surgery on Sleep Apnea in Patients With Acromegaly
- ClinicalTrials.gov ID
- NCT03526016
- Acronym / sponsor ID
- 1802032919
- Conditions
- Sleep Apnea
- Keywords
- Sleep Apnea, Acromegaly, Transsphenoidal surgery, Respiratory polygraphy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 21 Feb 2018 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 16 May 2018 (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.
Sleep apnea is common in acromegaly and both diseases are independently associated with hypertension and insulin resistance contributing to increased morbidity and mortality. Respiratory polygraphy is a simpler alternative to in-laboratory polysomnography for the management of more symptomatic patients with obstructive sleep apnea.
The aim of this study is to evaluate the prevalence of sleep apnea by respiratory polygraphy, and to analyze the effect of transsphenoidal surgery on sleep apnea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary referral hospital
Key inclusion criteria (1 listed)
- patients with newly diagnosed acromegaly
Key exclusion criteria (1 listed)
- patients who can not undergo transsphenoidal surgery
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
Change in Respiratory disturbance index
Time frame: Baseline and 3 months after transsphenoidal surgery
Changes in respiratory events during sleep
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2021.
- Derived from this study: PubMed 38918903Cho J, Kim JH, Kim YH, Lee J. Obstructive Sleep Apnea Screening and Effects of Surgery in Acromegaly: A Prospective Study. Endocrinol Metab (Seoul). 2024 Aug;39(4):641-652. doi: 10.3803/EnM.2024.1933. Epub 2024 Jun 26.
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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.
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 Sleep Apnea, run by Seoul National University Hospital at 1 site in South Korea.
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 1 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: status not confirmed, as of the sponsor's last update on 20 Aug 2021. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jinwoo Lee, MD (82-2-2072-7593, realrain7@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respiratory disturbance index (time frame: Baseline and 3 months after transsphenoidal surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03526016, which also lists 1 linked publication.
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 20 Aug 2021.