NCT03526016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 20, 2021

Status Verified

August 1, 2021

Enrollment Period

3.8 years

First QC Date

May 2, 2018

Last Update Submit

August 18, 2021

Conditions

Sleep Apnea

Keywords

Sleep ApneaAcromegalyTranssphenoidal surgeryRespiratory polygraphy

Outcome Measures

Primary Outcomes (1)

  • Change in Respiratory disturbance index

    Changes in respiratory events during sleep

    Baseline and 3 months after transsphenoidal surgery

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Tertiary referral hospital

You may qualify if:

  • patients with newly diagnosed acromegaly

You may not qualify if:

  • patients who can not undergo transsphenoidal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110744, South Korea

RECRUITING

Related Publications (1)

  • 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.

    PMID: 38918903DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesAcromegaly

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesBone Diseases, EndocrineBone DiseasesMusculoskeletal DiseasesHyperpituitarismPituitary DiseasesHypothalamic DiseasesBrain DiseasesCentral Nervous System DiseasesEndocrine System Diseases

Central Study Contacts

Jinwoo Lee, MD

CONTACT

82-2-2072-7593realrain7@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 16, 2018

Study Start

February 21, 2018

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

August 20, 2021

Record last verified: 2021-08

Locations

KR(1)