We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sleep Apnea in Acromegaly After Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03526016
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : August 20, 2021
Sponsor:
Information provided by (Responsible Party):
Jinwoo Lee, Seoul National University Hospital

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease
Sleep Apnea

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Transsphenoidal Surgery on Sleep Apnea in Patients With Acromegaly
Actual Study Start Date : February 21, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Change in Respiratory disturbance index [ Time Frame: Baseline and 3 months after transsphenoidal surgery ]
    Changes in respiratory events during sleep


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Tertiary referral hospital
Criteria

Inclusion Criteria:

  • patients with newly diagnosed acromegaly

Exclusion Criteria:

  • patients who can not undergo transsphenoidal surgery
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526016


Contacts
Layout table for location contacts
Contact: Jinwoo Lee, MD 82-2-2072-7593 realrain7@gmail.com

Locations
Layout table for location information
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110744
Contact: Jinwoo Lee, MD    82-2-2072-7593    realrain7@gmail.com   
Sponsors and Collaborators
Seoul National University Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Jinwoo Lee, Associate professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03526016    
Other Study ID Numbers: 1802032919
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: August 20, 2021
Last Verified: August 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jinwoo Lee, Seoul National University Hospital:
Sleep Apnea
Acromegaly
Transsphenoidal surgery
Respiratory polygraphy
Additional relevant MeSH terms:
Layout table for MeSH terms
Acromegaly
Apnea
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
 Bone Diseases, Endocrine
Bone Diseases
Musculoskeletal Diseases
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Endocrine System Diseases