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

Koç University

Status: Enrolling

Conditions: Obstructive Sleep Apnea

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

Study type: Observational

Funder types: Other

Identifiers

NCT02784977

09.2016.311

Details and patient eligibility

About

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.

Full 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

Enrollment: 10,000 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

10,000 participants in 2 patient groups

Obstructive Sleep Apnea (OSA)

Description:

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.

Treatment:

Procedure: Uvuloplasty

Device: Intraoral device (IOD)

Other: Conservative treatment

Device: Positive Airway Pressure (PAP)

No-OSA

Description:

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