Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE
- Conditions
- Sleep Apnea Syndromes
- Interventions
- Device: Manometry and possibly DISE
- 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
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
- Arm && Interventions
Group Intervention Description Sleep apnea, Manometry and possibly DISE Manometry and possibly DISE Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy.
- 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