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

Sleep-related Respiratory Disorder Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04448470
• Other study ID #: 19-002
• Status: Recruiting
• Start date: June 24, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: June 2020
• Source: Heinrich-Heine University, Duesseldorf
• Contact: Stefanie Keymel, MD
• Phone: +492118118800
• Email: ctsu[@]med.uni-duesseldorf.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Disease
• Respiration Disorders
• Respiratory Tract Diseases
• Sleep-related Respiratory Disorder
• Sleepiness

Intervention

Other:
• Questionnaire for recording daytime sleepiness over the course of the day
Questionnaire for recording daytime sleepiness over the course of the day
• Anamnesis and physicial examination
Anamnesis and physical examination, e.g. medication, comorbidities, complaints
• 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.
• 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.

Locations

Country	Name	City	State
Germany	Heinrich-Heine-University	Düsseldorf	North Rhine-Westphalia
Germany	Lung and Allergy Centre	Neuss	North Rhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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