NCT02969551UnknownNot Applicable
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE
Technical University of Munich1 site in 1 country30 target enrollmentStarted: January 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Detection of obstruction depending of sleep stage
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Detection of obstruction depending of sleep stage
Time Frame: 8
Secondary Outcomes
- Comparing the manometry findings to DISE(1 Hour)
Investigators
Study Sites (1)
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