Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04448470
Recruitment Status : Recruiting
First Posted : June 25, 2020
Last Update Posted : June 25, 2020
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf

Brief Summary:
It is not yet known whether an analysis of daytime sleepiness over the course of the day can predict the diagnosis or severity of sleep apnea. The goal of the study is to examine whether a psychometric determination of daytime sleepiness can adequately and practicably record daytime sleepiness in patients with mainly sleep apnea in comparison to other standardized methods.

Condition or disease Intervention/treatment
Sleep-related Respiratory Disorder Other: Questionnaire for recording daytime sleepiness over the course of the day Other: Anamnesis and physicial examination Other: Questionnaire for quantifying daytime sleepiness Diagnostic Test: Pulmonary function test Diagnostic Test: Polygraphy

Detailed Description:

Detailed Description: Sleep-related respiratory disorders are a common disease in the general population. Untreated sleep apnea is associated with an increased risk of accidents, an increased risk of perioperative complications and various cardiovascular diseases such as arterial hypertension, coronary heart disease or stroke. Sleep apnea is often undetected. As part of the diagnosis of sleep apnea, screening is usually carried out to assess the probability of pre-testing before a sleep medical examination by means of anamnesis, examination and recording of risk factors and comorbidities. Questionnaires play a decisive role here. The Epworth Sleepiness Scale (ESS) or the STOP BANG questionnaires are often used for this purpose. ESS asks about the probability of falling asleep in different situations. With STOP BANG, the points daytime tiredness, snoring, breathing stops and various risk factors such as age, sex, neck circumference, high blood pressure and overweight are asked. The quality of the questionnaire used to assess the risk of sleep apnea is of crucial importance, as it is usually the basis for the decision whether or not to perform further sleep medical diagnostics. To date, there is no established, easy-to-use method for measuring daytime sleepiness during the day. However, it can be assumed that the degree of daytime sleepiness can predict the presence of sleep apnea. In a proof-of-concept study, the psychometric determination of daytime sleepiness in a time series on one day in patients with mainly sleep apnea will be measured.

The following questions should be answered:

  1. Does daytime sleepiness in patients with sleep apnea measured by a scale-based, psychometric time-series test show one or more characteristic patterns over the day?
  2. Is there a relation between the degree of the scale based psychometric time series test for daytime sleepiness and the severity of sleep apnea?
  3. Is the test quality of the scale based psychometric time series test for predicting sleep apnea better than the established Epworth Sleepiness Scale or STOP BANG questionnaires.

The quantification of daytime sleepiness can potentially be of crucial importance both for diagnostic procedures and for the assessment of the use of therapeutic measures.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comparison Between the Situational and the Time-of-day Recording of Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder
Actual Study Start Date : June 24, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Group/Cohort Intervention/treatment
patients with a clinical suspicion of sleep apnea (n=150)
patients with a clinical suspicion of sleep apnea
Other: Questionnaire for recording daytime sleepiness over the course of the day
Questionnaire for recording daytime sleepiness over the course of the day

Other: Anamnesis and physicial examination
Anamnesis and physical examination, e.g. medication, comorbidities, complaints

Other: Questionnaire for quantifying daytime sleepiness
the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire

Diagnostic Test: Pulmonary function test
The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.

Diagnostic Test: Polygraphy
Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position.

healthy subjects (n=10)
healthy subjects
Other: Questionnaire for recording daytime sleepiness over the course of the day
Questionnaire for recording daytime sleepiness over the course of the day

Other: Anamnesis and physicial examination
Anamnesis and physical examination, e.g. medication, comorbidities, complaints

Other: Questionnaire for quantifying daytime sleepiness
the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire

Diagnostic Test: Pulmonary function test
The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.

Diagnostic Test: Polygraphy
Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position.




Primary Outcome Measures :
  1. Prediction of Sleep Apnea [ Time Frame: at Baseline ]
    the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients with the clinical suspicion of sleep apnea and healthy subject

The healthy subjects will be recruited at the Lung and Allergy Centre, Practice for Internal Medicine, Pneumology, Allergology, Sleep and Sports Medicine Neuss in the clinical routine. The patients are from the Lung and Allergy Centre, Practice for Internal Medicine, Pneumology, Allergology, Sleep and Sports Medicine in Neuss and from the Div. of Cardiology, Pulmonary Disease and Vascular Medicine from the University Hospital Düsseldorf.

Criteria

Inclusion criteria for patients

  • Age 18-80 years
  • Written informed consent to participate in this study
  • Patients with a clinical suspicion of sleep apnea

Exclusion criteria for patients:

  • Age <18 years
  • Lack of consent to participate in the study
  • Lack of willingness and ability to participate in the study
  • Pregnancy and breast feeding period

Inclusion criteria for healthy subjects:

  • Age 18-45 years
  • no internal or psychiatric illness requiring therapy
  • not long-term drug therapy
  • no known sleep apnea.
  • Written consent to participate in this study

Exclusion criteria for healthy subjects:

  • Patients with sleep apnea
  • Age <18 years or ≥ 45 years
  • Lack of consent to participate in the study
  • Pregnancy and breast feeding period
  • Lack of willingness and ability to participate in the study

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): NCT04448470


Contacts
Layout table for location contacts
Contact: Stefanie Keymel, MD +492118118800 ctsu@med.uni-duesseldorf.de
Contact: Rabea Wagstaff, M.A. +492118118914 ctsu@med.uni-duesseldorf.de

Locations
Layout table for location information
Germany
Heinrich-Heine-University Recruiting
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Contact: Stefanie Keymel, MD    +492118118800    ctsu@med.uni-duesseldorf.de   
Contact: Rabea Wagstaff, M.A.       ctsu@med.uni-duesseldorf.de   
Principal Investigator: Stefanie Keymel, MD         
Sub-Investigator: Stefan Krüger, MD         
Sub-Investigator: Malte Kelm, MD         
Lung and Allergy Centre Recruiting
Neuss, North Rhine-Westphalia, Germany, 41462
Contact: Johannes Uerscheln, MD         
Sub-Investigator: Johannes Uerscheln, MD         
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Investigators
Layout table for investigator information
Study Chair: Malte Kelm, Prof. Dr. University Hospital Düsseldorf
Layout table for additonal information
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Principle Investigator Dr. Stefanie Keymel, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT04448470    
Other Study ID Numbers: 19-002
First Posted: June 25, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
daytime sleepiness
respiratory disorder
sleep apnea
Additional relevant MeSH terms:
Layout table for MeSH terms
Respiration Disorders
Disease
Sleepiness
Respiratory Tract Diseases
Pathologic Processes
Signs and Symptoms