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

Sleep Apnea Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02969551
• Other study ID #: 88/14
• Status: Recruiting
• Phase: N/A
• First received: November 17, 2016
• Last updated: March 16, 2017
• Start date: January 2014
• Est. completion date: March 2017

Study information

• Verified date: March 2017
• Source: Technische Universität München
• Contact: Clemens Heiser, MD
• Phone: +49 8941409583
• Email: hno[@]heiser-online.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: March 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Obstruction
• Sleep Apnea Syndromes

Intervention

Device:
• Manometry and possibly DISE
A Manometry is performed on all patients. After it in some Patient DISE is followed

Locations

Country	Name	City	State
Germany	Klinik für Hals- Nasen- Ohrenheilkunde	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of obstruction depending of sleep stage		8
Secondary	Comparing the manometry findings to DISE		1 Hour