Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE

• Conditions: Sleep Apnea Syndromes

• Registration Number: NCT02969551
• Lead Sponsor: Technical University of Munich

Brief Summary

Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2016-11-17
• Study First Submitted QC: 2016-11-18
• Study First Posted: 2016-11-21
• Primary Completion: 2016-12
• Status Verified: 2017-03
• Study Completion: 2017-03
• Last Update Submitted: 2017-03-16
• Last Update Posted: 2017-03-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Apnea-Hypopnea-Index (AHI) ≥ 5.

Exclusion Criteria

• age <18 years;
• body mass index (BMI) of >35 kg/m2; active infection;
• previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (> 60g ethanol per day or > 150g ethanol per week) or sedatives; illicit drug use;
• chronic obstructive pulmonary disease.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Detection of obstruction depending of sleep stage	8

Secondary Outcome Measures

Name	Time	Method
Comparing the manometry findings to DISE	1 Hour

Trial Locations

Locations (1)

Klinik für Hals- Nasen- Ohrenheilkunde; 🇩🇪 München, Bayern, Germany