Detection of Airway Obstruction by Manometry in Different... | NCT02969551

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

NCT02969551

Sponsor

Technical University of Munich

Status

Unknown status

Last Update Posted

Mar 20, 2017Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Sleep Apnea Syndromes

Interventions

Manometry and possibly DISE

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2016Actual

Completion Date

Mar 2017Estimated

First Submitted Date

Nov 17, 2016

First Submission Date that Met QC Criteria

Nov 18, 2016

First Posted Date

Nov 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2017

Last Update Posted Date

Mar 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sleep apnea, Manometry and possibly DISE		Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy.	Device: Manometry and possibly DISE

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Manometry and possibly DISE	Device	A Manometry is performed on all patients. After it in some Patient DISE is followed	Sleep apnea, Manometry and possibly DISE

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Detection of obstruction depending of sleep stage		8

Secondary Outcomes

Measure	Description	Time Frame
Comparing the manometry findings to DISE		1 Hour

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patient with a diagnosed obstructive sleep apnea Syndrome.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Clemens Heiser, MD	Contact	+49 8941409583		hno@heiser-online.com
Günther M Edenharter, MD	Contact	+49 89 41405051		g.edenharter@tum.de

Overall Officials

Name	Affiliation	Role
Clemens Heiser, MD	attending doctor in ENT	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinik für Hals- Nasen- Ohrenheilkunde	Recruiting	München	Bavaria	81675	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012891	Sleep Apnea Syndromes

Ancestor Terms

ID	Term
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D020919	Sleep Disorders, Intrinsic

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008365	Manometry

Ancestor Terms

ID	Term
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided