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

Study Overview
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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

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Device: Positive Airway Pressure (PAP)
* Device: Intraoral device (IOD)
* Procedure: Uvuloplasty
* Other: Conservative treatment


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Obstructive Sleep Apnea (OSA)<br>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)<br>* Treatment of OSA with PAP<br>Device: Intraoral device (IOD)<br>* Treatment of OSA with IOD<br>Procedure: Uvuloplasty<br>* Uvuloplasty<br>Other: Conservative treatment<br>* No active intervention<br>|
| No-OSA<br>Patients with apnea hypopnea index less than 5 events per hour. No intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Through study completion, an average of 7 years | 
| Incidence of cardiovascular diseases and mortality | Number of patients who have died or developed cardiovascular diseases | Through study completion, an average of 7 years |