TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study

Obstructive Sleep Apnea Clinical Trial

— TURKAPNE  

Official title:

TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02784977
• Other study ID #: 09.2016.311
• Status: Recruiting
• Start date: October 3, 2017
• Est. completion date: December 31, 2027

Study information

• Verified date: October 2022
• Source: Koç University
• Contact: Yüksel Peker, Prof
• Phone: +905443483866
• Email: yukselpeker26[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Primary aim of the TURKAPNE (The Turkish Sleep Apnea Database) study is to generate a cross-sectional nationwide database to define clinical and polysomnographic characteristics of the sleep apnea patients in Turkey. Associations of phenotypes of sleep apnea patients with metabolic and cardiovascular diseases as well as risk for traffic accidents will be explored as secondary aims. Impact of treatment of sleep apnea on metabolic and cardiovascular complications as well as compliance with positive airway pressure treatment will be further explored longitudinally.

Description:

All subjects undergoing sleep study for suspicion of obstructive sleep apnea will be registered in a web-based national database regarding:

• Anthropometric data, educational status, driving licence,

• Smoking and alcohol use

• Comorbidities, and drug use

• Questionnaires, excessive daytime sleepiness

• Polygraphic and polysomnographic findings

• Blood pressure measurements

• If taken, blood glucose, lipids and other biochemical markers

• If measured, lung function test results

• If measured, echocardiography findings

• Follow-up data regarding treatment modality and compliance

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea

• Ability to read and speak

• Signed informed consent.

Exclusion Criteria:

• subjects who use positive airway pressure

• subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies

• subjects with alcohol dependency

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• Positive Airway Pressure (PAP)
Treatment of OSA with PAP
• Intraoral device (IOD)
Treatment of OSA with IOD

Procedure:
• Uvuloplasty
Uvuloplasty

Other:
• Conservative treatment
No active intervention

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul

Sponsors (17)

Lead Sponsor

Collaborator

Koç University

Afyon Kocatepe University School of Medicine, Afyon, Turkey, Baskent University Hospital, Istanbul, Turkey, Dicle University School of Medicine, Diyarbakir, Turkey, Diskapi Yildirim Beyazit Education and Research Hospital, Dokuz Eylul University, Ege University School of Medicine, Izmir, Turkey, Hitit University School of Medicine, Corum, Turkey, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Istanbul University Cerrahpasa School of Medicine, Istanbul, Turkey, Kocaeli Education and Research Hospital, Kocaeli, Turkey, Marmara University, Namik Kemal University School of Medicine, Tekirdag, Pamukkale University School of Medicine, Denizli, Turkey, Suleyman Demirel University School of Medicine, Isparta, Turkey, Trakya University School of Medicine, Edirne, Turkey, Uludag University School of Medicine, Bursa, Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Peker Y, Basoglu ÖK, Firat H; TURKAPNE Study Group. Rationale and Design of the Turkish Sleep Apnea Database - TURKAPNE: A National, Multicenter, Observational, Prospective Cohort Study. Turk Thorac J. 2018 Jul;19(3):136-140. doi: 10.5152/TurkThoracJ.2018.18097. Epub 2018 Jul 1. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolic and cardiovascular diseases in obstructive sleep apnea phenotypes	The association of sleep apnea severity indices such as Apnea-Hypopnea Index and Oxygen Desaturation Index during Rapid Eye Movement (REM) sleep and non-REM sleep with self-reported diabetes mellitus and cardiovascular diseases will be explored.	Up to three years
Secondary	Sex differences in obstructive sleep apnea phenotypes	Possible sex differences in REM-dependent sleep apnea, positional sleep apnea and its association with metabolic and cardiovascular diseases will be explored	Up to three years
Secondary	Adherence to positive airway pressure treatment in obstructive sleep apnea	Predictors of adherence to positive airway pressure treatment (defined as device usage at least 4 hours of night during at least 70% of study period) in obstructive sleep apnea	Through study completion, an average of 7 years
Secondary	Incidence of cardiovascular diseases and mortality	Number of patients who have died or developed cardiovascular diseases	Through study completion, an average of 7 years