Koç University Hospital
Istanbul, TR 34010, Turkey (Türkiye)
Location status: Recruiting
Location contact
BARAN BALCAN, MD
CONTACT
YÜKSEL PEKER, MD, PhD, Prof
CONTACT
Recruiting
NCT Number: NCT02784977
TURKAPNE - The Turkish Sleep Apnea Database: A National, Multicenter, Observational, Prospective Cohort 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.
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Positive Airway Pressure (PAP)
DeviceTreatment of OSA with PAP
Intraoral device (IOD)
DeviceTreatment of OSA with IOD
Uvuloplasty
ProcedureUvuloplasty
Conservative treatment
OtherNo active intervention
Primary outcomes
-
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.
Secondary outcomes
-
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
-
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
-
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
Study contacts
Contact information is provided by the study sponsor or research team.
Baran Balcan, Assoc. Prof
CONTACT
Yüksel Peker, Prof
CONTACT
Sponsors and collaborators
Lead sponsor
Koç University
Other
Collaborators
- Afyon Kocatepe University School of Medicine, Afyon, Turkey
- Baskent University Ankara Hospital
- Dicle University School of Medicine, Diyarbakir, Turkey
- Diskapi Yildirim Beyazit Education and Research Hospital
- Dokuz Eylul University
- Ege University School of Medicine, Izmir, Turkey
- Hitit University School of Medicine, Corum, Turkey
- Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
- Istanbul University - Cerrahpasa
- Kocaeli Education and Research Hospital, Kocaeli, Turkey
- Marmara University
- Namik Kemal University School of Medicine, Tekirdag
- Pamukkale University School of Medicine, Denizli, Turkey
- Suleyman Demirel University School of Medicine, Isparta, Turkey
- Trakya University
- Uludag University
Registry information
Acronym: TURKAPNE
Important dates
- Study start
- 2017
- Primary completion
- 2024
- Study completion
- 2027
- First posted
- May 27, 2016
- Registry last updated
- Oct 13, 2022
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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