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

Comparison Between the Situational and the Time-of-day Recording of Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder

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.

Study Overview

• Status: Unknown
• Conditions: Sleep-related Respiratory Disorder
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Anticipated): 130

Contacts and Locations

• Study Contact: Name: Stefanie Keymel, MD; Phone Number: +492118118800; Email: ctsu@med.uni-duesseldorf.de
• Study Contact Backup: Name: Rabea Wagstaff, M.A.; Phone Number: +492118118914; Email: ctsu@med.uni-duesseldorf.de

Study Locations

• Germany
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Recruiting
      • Heinrich-Heine-University
      • Contact: Stefanie Keymel, MD; Phone Number: +492118118800; Email: ctsu@med.uni-duesseldorf.de
      • Contact: Rabea Wagstaff, M.A.; Email: ctsu@med.uni-duesseldorf.de
      • Principal Investigator: Stefanie Keymel, MD
      • Sub-Investigator: Stefan Krüger, MD
      • Sub-Investigator: Malte Kelm, MD
    • Neuss, North Rhine-Westphalia, Germany, 41462
      • Recruiting
      • Lung and Allergy Centre
      • Contact: Johannes Uerscheln, MD
      • Sub-Investigator: Johannes Uerscheln, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prediction of Sleep Apnea	the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea	at Baseline

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Study Chair: Malte Kelm, Prof. Dr., University Hospital Düsseldorf

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 24, 2020
• Primary Completion (ANTICIPATED): June 30, 2021
• Study Completion (ANTICIPATED): June 30, 2021

Study Registration Dates

• First Submitted: June 24, 2020
• First Submitted That Met QC Criteria: June 24, 2020
• First Posted (ACTUAL): June 25, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 25, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: sleep apnea; daytime sleepiness; respiratory disorder
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Respiration Disorders; Respiratory Tract Diseases; Disorders of Excessive Somnolence; Sleepiness
• Other Study ID Numbers: 19-002 (Zealand Pharma)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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