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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02969551
Enrollment
30
Registered
2016-11-21
Start date
2014-01-31
Completion date
2017-03-31
Last updated
2017-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

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.

Interventions

DEVICEManometry and possibly DISE

A Manometry is performed on all patients. After it in some Patient DISE is followed

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Detection of obstruction depending of sleep stage8

Secondary

MeasureTime frame
Comparing the manometry findings to DISE1 Hour

Countries

Germany

Contacts

Primary ContactClemens Heiser, MD
hno@heiser-online.com+49 8941409583
Backup ContactGünther M Edenharter, MD
g.edenharter@tum.de+49 89 41405051

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026