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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01775241
Other study ID # 10-080
Secondary ID
Status Completed
Phase N/A
First received January 22, 2013
Last updated January 7, 2014
Start date October 2011
Est. completion date March 2013

Study information

Verified date January 2014
Source RWTH Aachen University
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial Summary

It is the objective of this study to collect scientific data of sleep apnoea syndrome patients´ cardiac and respiratory function by additional sensors.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- patients with supected sleep apnoea syndrome and scheduled diagnosis at a sleep laboratory

- male and female patients aged at least 18 years

- persons who understand and follow the instructions of the study staff

- singed informed consent

Exclusion Criteria:

- persons being housed in an institution by court or governmental order

- pregnancy or breastfeeding

- patients who are not able to consent

- acute or chronic inflammations of the external and middle auditory canal

- abnormal anatomic proportionsof the external and middle auditory canal which are pathological or congenital, for example limitation of the auditory canal

- persons in a dependence or in an employment contract to the investigator

- participation in another study at the same time

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Univeristy Hospital Aachen Aachen North Rhine Westfalia

Sponsors (1)

Lead Sponsor Collaborator
RWTH Aachen University

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Data collection 1 night No