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Sleep Apnoea Syndrome Without Chronic Heart Failure

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01775241
First Posted: January 24, 2013
Last Update Posted: January 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
RWTH Aachen University
  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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01775241


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

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01775241     History of Changes
Other Study ID Numbers: 10-080
First Submitted: January 22, 2013
First Posted: January 24, 2013
Last Update Posted: January 8, 2014
Last Verified: January 2014

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