Sleep Apnoea Syndrome Without Chronic Heart Failure

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01775241
First received: January 22, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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


Condition
Sleep Apnoea Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sleep Apnoea Syndrome Without Chronic Heart Failure

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Data collection [ Time Frame: 1 night ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: October 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with or with supected sleep apnoea syndrome

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01775241

Locations
Germany
Univeristy Hospital Aachen
Aachen, North Rhine Westfalia, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01775241     History of Changes
Other Study ID Numbers: 10-080
Study First Received: January 22, 2013
Last Updated: January 7, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Apnea
Heart Failure
Sleep Apnea Syndromes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Heart Diseases
Cardiovascular Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014