Clinical trial NCT02784977: TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study
Official title: TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Sleep Apnea
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Ege University School of Medicine, Izmir, Turkey
name: Dokuz Eylul University
name: Diskapi Yildirim Beyazit Education and Research Hospital
name: Uludag University School of Medicine, Bursa, Turkey
name: Dicle University School of Medicine, Diyarbakir, Turkey
name: Namik Kemal University School of Medicine, Tekirdag
name: Suleyman Demirel University School of Medicine, Isparta, Turkey
name: Istanbul University - Cerrahpasa
name: Pamukkale University School of Medicine, Denizli, Turkey
name: Trakya University School of Medicine, Edirne, Turkey
name: Afyon Kocatepe University School of Medicine, Afyon, Turkey
name: Hitit University School of Medicine, Corum, Turkey
name: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
name: Kocaeli Education and Research Hospital, Kocaeli, Turkey
name: Baskent University Hospital, Istanbul, Turkey
name: Marmara University
First posted: 2016-05-27
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All consecutive patients referred to the sleep clinics for suspicion of sleep apnea

Brief 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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Metabolic and cardiovascular diseases in obstructive sleep apnea phenotypes
timeFrame: Up to three years
Secondary outcomes:
measure: Sex differences in obstructive sleep apnea phenotypes
timeFrame: Up to three years
measure: Adherence to positive airway pressure treatment in obstructive sleep apnea
timeFrame: Through study completion, an average of 7 years
measure: Incidence of cardiovascular diseases and mortality
timeFrame: Through study completion, an average of 7 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
Study officials:
affiliation: Koç University School of Medicine, Dept of Pulmonary Medicine
name: Yüksel Peker, Prof
role: STUDY_CHAIR
affiliation: Ege University School of Medicine
name: Özen Kacmaz Basoglu, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Ankara Diskapi Yildirim Beyazit Education and Research Hospital
name: Hikmet Firat, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Dokuz Eylul University Medical School
name: Oya Itil, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Uludag University Medical School
name: Mehmet Karadag, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Namik Kemal University Medical School
name: Nejat Altintas, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Dicle University Medical School
name: Gökhan Kirbas, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Süleyman Demirel University Medical School
name: Önder Öztürk, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Cerrahpasa Medical School
name: Derya Karadeniz, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Pamukkale University Medical School
name: Nese Dursunoglu, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Trakya University Medical School
name: Gundeniz Altiay, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyon Kocatepe University Medical School
name: Ersin Günay, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Sureyyapasa Education and Research Hospital
name: Sema Sarac, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kocaeli Education and Research Hospital
name: Zahide Yilmaz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul Baskent University Hospital
name: Aylin Ozsancak Ugurlu, Assoc. Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University, Faculty of Medicine, Department of Neurology
name: Kadriye Agan Yildirim, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Corum Hitit University
name: Sertac Arslan, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Peker Y, Basoglu OK, 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.