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

October 12, 2022 updated by: Koç University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)
Treatment of OSA with PAP
Device: Intraoral device (IOD)
Treatment of OSA with IOD
Procedure: Uvuloplasty
Uvuloplasty
Other: Conservative treatment
No active intervention
No-OSA
Patients with apnea hypopnea index less than 5 events per hour. No intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolic and cardiovascular diseases in obstructive sleep apnea phenotypes
Time Frame: Up to three years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sex differences in obstructive sleep apnea phenotypes
Time Frame: Up to three years
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
Adherence to positive airway pressure treatment in obstructive sleep apnea
Time Frame: Through study completion, an average of 7 years
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
Incidence of cardiovascular diseases and mortality
Time Frame: Through study completion, an average of 7 years
Number of patients who have died or developed cardiovascular diseases
Through study completion, an average of 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Koç University

Collaborators

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

Investigators

  • Study Chair: Yüksel Peker, Prof, Koç University School of Medicine, Dept of Pulmonary Medicine
  • Principal Investigator: 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, İstanbul University Cerrahpaşa 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2017

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2027

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 24, 2016

First Posted (Estimate)

May 27, 2016

Study Record Updates

Last Update Posted (Actual)

October 13, 2022

Last Update Submitted That Met QC Criteria

October 12, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 09.2016.311

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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