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

NCT ID: NCT02784977

Last Updated: 2022-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2027-12-31

Brief Summary

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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

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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

Conditions

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Obstructive Sleep Apnea

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Obstructive Sleep Apnea (OSA)

Patients with apnea hypopnea index of at least 5 events per hour. Intervention with positive airway pressure, or intraoral device, or uvuloplasty, or conservative treatment.

Positive Airway Pressure (PAP)

Intervention Type DEVICE

Treatment of OSA with PAP

Intraoral device (IOD)

Intervention Type DEVICE

Treatment of OSA with IOD

Uvuloplasty

Intervention Type PROCEDURE

Uvuloplasty

Conservative treatment

Intervention Type OTHER

No active intervention

No-OSA

Patients with apnea hypopnea index less than 5 events per hour. No intervention.

No interventions assigned to this group

Interventions

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Positive Airway Pressure (PAP)

Treatment of OSA with PAP

Intervention Type DEVICE

Intraoral device (IOD)

Treatment of OSA with IOD

Intervention Type DEVICE

Uvuloplasty

Uvuloplasty

Intervention Type PROCEDURE

Conservative treatment

No active intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ege University School of Medicine, Izmir, Turkey

UNKNOWN

Sponsor Role collaborator

Dokuz Eylul University

OTHER

Sponsor Role collaborator

Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role collaborator

Uludag University School of Medicine, Bursa, Turkey

UNKNOWN

Sponsor Role collaborator

Dicle University School of Medicine, Diyarbakir, Turkey

UNKNOWN

Sponsor Role collaborator

Namik Kemal University School of Medicine, Tekirdag

OTHER

Sponsor Role collaborator

Suleyman Demirel University School of Medicine, Isparta, Turkey

UNKNOWN

Sponsor Role collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role collaborator

Pamukkale University School of Medicine, Denizli, Turkey

UNKNOWN

Sponsor Role collaborator

Trakya University School of Medicine, Edirne, Turkey

UNKNOWN

Sponsor Role collaborator

Afyon Kocatepe University School of Medicine, Afyon, Turkey

UNKNOWN

Sponsor Role collaborator

Hitit University School of Medicine, Corum, Turkey

UNKNOWN

Sponsor Role collaborator

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Kocaeli Education and Research Hospital, Kocaeli, Turkey

UNKNOWN

Sponsor Role collaborator

Baskent University Ankara Hospital

OTHER

Sponsor Role collaborator

Marmara University

OTHER

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yüksel Peker, Prof

Role: STUDY_CHAIR

Koç University School of Medicine, Dept of Pulmonary Medicine

Özen Kacmaz Basoglu, Prof

Role: PRINCIPAL_INVESTIGATOR

Ege University School of Medicine

Hikmet Firat, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Ankara Diskapi Yildirim Beyazit Education and Research Hospital

Oya Itil, Prof

Role: PRINCIPAL_INVESTIGATOR

Dokuz Eylul University Medical School

Mehmet Karadag, Prof

Role: PRINCIPAL_INVESTIGATOR

Uludag University Medical School

Nejat Altintas, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Namik Kemal University Medical School

Gökhan Kirbas, Prof

Role: PRINCIPAL_INVESTIGATOR

Dicle University Medical School

Önder Öztürk, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Süleyman Demirel University Medical School

Derya Karadeniz, Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul University Cerrahpasa Medical School

Nese Dursunoglu, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University Medical School

Gundeniz Altiay, Prof

Role: PRINCIPAL_INVESTIGATOR

Trakya University Medical School

Ersin Günay, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Afyon Kocatepe University Medical School

Sema Sarac, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Sureyyapasa Education and Research Hospital

Zahide Yilmaz, MD

Role: PRINCIPAL_INVESTIGATOR

Kocaeli Education and Research Hospital

Aylin Ozsancak Ugurlu, Assoc. Prof

Role: PRINCIPAL_INVESTIGATOR

Istanbul Baskent University Hospital

Kadriye Agan Yildirim, Prof

Role: PRINCIPAL_INVESTIGATOR

Marmara University, Faculty of Medicine, Department of Neurology

Sertac Arslan, Assist Prof

Role: PRINCIPAL_INVESTIGATOR

Corum Hitit University

Locations

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Koç University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Yüksel Peker, Prof

Role: CONTACT

+905443483866

Baran Balcan, Assoc. Prof

Role: CONTACT

+905304142308

Facility Contacts

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YÜKSEL PEKER, MD, PhD, Prof

Role: primary

+905443483866

BARAN BALCAN, MD

Role: backup

+905304142308

References

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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.

Reference Type BACKGROUND
PMID: 30083405 (View on PubMed)

Pihtili A, Kiyan E, Balcan B, Arbatli S, Cilli A, Altintas N, Ugurlu AO, Gurkan CG, Tasbakan MS, Dursunoglu N, Ogun H, Annakkaya AN, Sokucu SN, Firat H, Basoglu OK, Peker Y; Turkapne Study Group. Sex differences in clinical and polysomnographic features of obstructive sleep apnea: The Turkish sleep apnea database (TURKAPNE) cohort. Sleep Med. 2025 Feb;126:228-234. doi: 10.1016/j.sleep.2024.12.018. Epub 2024 Dec 17.

Reference Type DERIVED
PMID: 39721358 (View on PubMed)

Other Identifiers

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09.2016.311

Identifier Type: -

Identifier Source: org_study_id

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