Sleep Apnea in Acromegaly After Surgery | NCT03526016

Studies
Sleep Apnea in Acromegaly After Surgery

NCT03526016

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Aug 20, 2021Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Sleep Apnea

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 21, 2018Actual

Primary Completion Date

Dec 2021Estimated

Completion Date

Dec 2021Estimated

First Submitted Date

May 2, 2018

First Submission Date that Met QC Criteria

May 15, 2018

First Posted Date

May 16, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2021

Last Update Posted Date

Aug 20, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jinwoo Lee, Associate professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Respiratory disturbance index	Changes in respiratory events during sleep	Baseline and 3 months after transsphenoidal surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with newly diagnosed acromegaly

Exclusion Criteria:

patients who can not undergo transsphenoidal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Tertiary referral hospital

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jinwoo Lee, MD	Contact	82-2-2072-7593		realrain7@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110744	South Korea

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38918903	Derived	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.

ID	Term
D012891	Sleep Apnea Syndromes
D000172	Acromegaly

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic