Obstructive Sleep ApneaTURKAPNENCT02784977
TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study
An observational study of Obstructive Sleep Apnea, run by Koç University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Positive Airway Pressure (PAP), Intraoral device (IOD) and Uvuloplasty
- Type of treatment
- Medical device, Surgery or procedure
- How many people
- 10,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Oct 2017to 31 Dec 2027
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All consecutive patients referred to the sleep clinics for suspicion of sleep apnea
Who may be able to join
- Consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea
- Ability to read and speak
- Signed informed consent.
Who cannot join
- subjects who use positive airway pressure
- subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
- subjects with alcohol dependency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital
Istanbul, TR 34010
YÜKSEL PEKER, MD, PhD, Prof, +905443483866, yukselpeker26@gmail.com
BARAN BALCAN, MD, +905304142308, drbaranbalcan@gmail.com
About this study
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.
Read the 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
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Positive Airway Pressure (PAP), Intraoral device (IOD), Uvuloplasty, Conservative treatment
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive Airway Pressure (PAP)Device
Treatment of OSA with PAP
Intraoral device (IOD)Device
Treatment of OSA with IOD
UvuloplastyProcedure or surgery
Uvuloplasty
Conservative treatmentOther
No active intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to three years
Secondary outcomes (3)
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
Measured: Up to three years
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
Measured: Through study completion, an average of 7 years
Incidence of cardiovascular diseases and mortality
Number of patients who have died or developed cardiovascular diseases
Measured: Through study completion, an average of 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start3 Oct 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Ege University School of Medicine, Izmir, Turkey, Dokuz Eylul University, Diskapi Yildirim Beyazit Education and Research Hospital, Uludag University, 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, Pamukkale University, Trakya University, Afyon Kocatepe University School of Medicine, Afyon, Turkey, Hitit University School of Medicine, Corum, Turkey, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Kocaeli Education and Research Hospital, Kocaeli, Turkey, Baskent University Ankara Hospital, Marmara University
- Responsible party
- Sponsor
- Investigators
- Yüksel Peker, Prof, Study chair, Koç University School of Medicine, Dept of Pulmonary MedicineÖzen Kacmaz Basoglu, Prof, Principal investigator, Ege University School of MedicineHikmet Firat, Assoc. Prof, Principal investigator, Ankara Diskapi Yildirim Beyazit Education and Research HospitalOya Itil, Prof, Principal investigator, Dokuz Eylul University Medical SchoolMehmet Karadag, Prof, Principal investigator, Uludag University Medical SchoolNejat Altintas, Assoc. Prof, Principal investigator, Namik Kemal University Medical SchoolGökhan Kirbas, Prof, Principal investigator, Dicle University Medical SchoolÖnder Öztürk, Assoc. Prof, Principal investigator, Süleyman Demirel University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784977
- Sponsor's protocol ID
- 09.2016.311
- Acronym
- TURKAPNE
- Status last verified
- Oct 2022
- First submitted
- 18 May 2016
- Last updated
- 13 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 30083405Celik Y, Pihtili A, Kiyan E, Tasbakan MS, Basoglu OK, Aydin S, Cilli A, Dursunoglu N, Yetkin NA, Peker Y; TURKAPNE Study Group. Clinical and Polysomnographic Characteristics of Comorbid Insomnia and Sleep Apnoea: Findings From the TURKAPNE Cohort. J Sleep Res. 2026 Nov 3:e70500. doi: 10.1111/jsr.70500. Online ahead of print.
PubMed 42974656Gurkan CG, Pihtili A, Kiyan E, Tasbakan MS, Basoglu OK, Arbatli S, Aydin S, Cilli A, Dursunoglu N, Baran B, Peker Y; Turkapne Study Group. Diabetes mellitus is associated with increased prevalence and severity of COMISA: evidence from the nationwide TURKAPNE cohort. J Clin Sleep Med. 2026 Jul 2;22(1):103. doi: 10.1007/s44470-026-00109-4.
PubMed 42390661Pihtili 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.
PubMed 39721358
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02784977
- Acronym / sponsor ID
- TURKAPNE / 09.2016.311
- Conditions
- Obstructive Sleep Apnea
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Ege University School of Medicine, Izmir, Turkey, Dokuz Eylul University, Diskapi Yildirim Beyazit Education and Research Hospital, Uludag University, 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, Pamukkale University, Trakya University, Afyon Kocatepe University School of Medicine, Afyon, Turkey, Hitit University School of Medicine, Corum, Turkey, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Kocaeli Education and Research Hospital, Kocaeli, Turkey, Baskent University Ankara Hospital, Marmara University
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obstructive Sleep Apnea (OSA) | – | Device: Positive Airway Pressure (PAP), Device: Intraoral device (IOD), Procedure: Uvuloplasty, Other: Conservative treatmentPatients with apnea hypopnea index of at least 5 events per hour. Intervention with positive airway pressure, or intraoral device, or uvuloplasty, or conservative treatment. |
| No-OSA | – | –Patients with apnea hypopnea index less than 5 events per hour. No intervention. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients referred to the sleep clinics for suspicion of sleep apnea
Key inclusion criteria (3 listed)
- Consecutive adult patients undergoing sleep study for suspicion of obstructive sleep apnea
- Ability to read and speak
- Signed informed consent.
Key exclusion criteria (3 listed)
- subjects who use positive airway pressure
- subjects with limited life expectancy due to advanced renal disease or uncontrolled malignancies
- subjects with alcohol dependency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Positive Airway Pressure (PAP)Treatment of OSA with PAP | Device | Obstructive Sleep Apnea (OSA) |
| Intraoral device (IOD)Treatment of OSA with IOD | Device | Obstructive Sleep Apnea (OSA) |
| UvuloplastyUvuloplasty | Procedure or surgery | Obstructive Sleep Apnea (OSA) |
| Conservative treatmentNo active intervention | Other | Obstructive Sleep Apnea (OSA) |
Primary outcome
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.
3 secondary outcomes
Sex differences in obstructive sleep apnea phenotypes
Time frame: Up to three years
Adherence to positive airway pressure treatment in obstructive sleep apnea
Time frame: Through study completion, an average of 7 years
Incidence of cardiovascular diseases and mortality
Time frame: Through study completion, an average of 7 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 30083405Peker 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.
- Derived from this study: PubMed 42974656Celik Y, Pihtili A, Kiyan E, Tasbakan MS, Basoglu OK, Aydin S, Cilli A, Dursunoglu N, Yetkin NA, Peker Y; TURKAPNE Study Group. Clinical and Polysomnographic Characteristics of Comorbid Insomnia and Sleep Apnoea: Findings From the TURKAPNE Cohort. J Sleep Res. 2026 Nov 3:e70500. doi: 10.1111/jsr.70500. Online ahead of print.
- Derived from this study: PubMed 42390661Gurkan CG, Pihtili A, Kiyan E, Tasbakan MS, Basoglu OK, Arbatli S, Aydin S, Cilli A, Dursunoglu N, Baran B, Peker Y; Turkapne Study Group. Diabetes mellitus is associated with increased prevalence and severity of COMISA: evidence from the nationwide TURKAPNE cohort. J Clin Sleep Med. 2026 Jul 2;22(1):103. doi: 10.1007/s44470-026-00109-4.
- Derived from this study: PubMed 39721358Pihtili 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yüksel Peker, Prof study chair
Koç University School of Medicine, Dept of Pulmonary Medicine
Özen Kacmaz Basoglu, Prof principal investigator
Ege University School of Medicine
Hikmet Firat, Assoc. Prof principal investigator
Ankara Diskapi Yildirim Beyazit Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yüksel Peker, Prof (+905443483866, yukselpeker26@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Metabolic and cardiovascular diseases in obstructive sleep apnea phenotypes (time frame: Up to three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02784977, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2022.