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

NCT02784977 | Recruiting DMC

• 1 other identifier: 09.2016.311
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sex differences in obstructive sleep apnea phenotypes

  Up to three years

• Adherence to positive airway pressure treatment in obstructive sleep apnea

  Through study completion, an average of 7 years

• Incidence of cardiovascular diseases and mortality

  Through study completion, an average of 7 years

Study Arms (2)

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.

Device: Positive Airway Pressure (PAP); Device: Intraoral device (IOD); Procedure: Uvuloplasty; Other: Conservative treatment

No-OSA

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

Interventions

Positive Airway Pressure (PAP) DEVICE

Treatment of OSA with PAP

Obstructive Sleep Apnea (OSA)

Intraoral device (IOD) DEVICE

Treatment of OSA with IOD

Obstructive Sleep Apnea (OSA)

Uvuloplasty PROCEDURE

Uvuloplasty

Obstructive Sleep Apnea (OSA)

Conservative treatment OTHER

No active intervention

Obstructive Sleep Apnea (OSA)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All consecutive patients referred to the sleep clinics for suspicion of sleep apnea

You may qualify if:

• Consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea
• Ability to read and speak
• Signed informed consent.

You may not qualify if:

• subjects who use positive airway pressure
• subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
• subjects with alcohol dependency

Sponsors & Collaborators

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

Study Sites (1)

Koç University Hospital

Istanbul, TR 34010, Turkey (Türkiye)

RECRUITING

Related Publications (2)

• 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.

  PMID: 30083405 BACKGROUND

• 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.

  PMID: 39721358 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yüksel Peker, Prof

  Koç University School of Medicine, Dept of Pulmonary Medicine

  STUDY CHAIR

• Özen Kacmaz Basoglu, Prof

  Ege University School of Medicine

  PRINCIPAL INVESTIGATOR

• Hikmet Firat, Assoc. Prof

  Ankara Diskapi Yildirim Beyazit Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Oya Itil, Prof

  Dokuz Eylul University Medical School

  PRINCIPAL INVESTIGATOR

• Mehmet Karadag, Prof

  Uludag University Medical School

  PRINCIPAL INVESTIGATOR

• Nejat Altintas, Assoc. Prof

  Namik Kemal University Medical School

  PRINCIPAL INVESTIGATOR

• Gökhan Kirbas, Prof

  Dicle University Medical School

  PRINCIPAL INVESTIGATOR

• Önder Öztürk, Assoc. Prof

  Süleyman Demirel University Medical School

  PRINCIPAL INVESTIGATOR

• Derya Karadeniz, Prof

  Istanbul University Cerrahpasa Medical School

  PRINCIPAL INVESTIGATOR

• Nese Dursunoglu, Assoc. Prof

  Pamukkale University Medical School

  PRINCIPAL INVESTIGATOR

• Gundeniz Altiay, Prof

  Trakya University Medical School

  PRINCIPAL INVESTIGATOR

• Ersin Günay, Assoc. Prof

  Afyon Kocatepe University Medical School

  PRINCIPAL INVESTIGATOR

• Sema Sarac, MD

  Istanbul Sureyyapasa Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Zahide Yilmaz, MD

  Kocaeli Education and Research Hospital

  PRINCIPAL INVESTIGATOR

• Aylin Ozsancak Ugurlu, Assoc. Prof

  Istanbul Baskent University Hospital

  PRINCIPAL INVESTIGATOR

• Kadriye Agan Yildirim, Prof

  Marmara University, Faculty of Medicine, Department of Neurology

  PRINCIPAL INVESTIGATOR

• Sertac Arslan, Assist Prof

  Corum Hitit University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yüksel Peker, Prof

CONTACT

+905443483866; yukselpeker26@gmail.com

Baran Balcan, Assoc. Prof

CONTACT

+905304142308; drbaranbalcan@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2016
• First Posted: May 27, 2016
• Study Start: October 3, 2017
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2027
• Last Updated: October 13, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)