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

Heinrich-Heine University, Duesseldorf

Status: Unknown

Conditions: Sleep-related Respiratory Disorder

Treatments: Other: Anamnesis and physicial examination; Diagnostic Test: Polygraphy; Diagnostic Test: Pulmonary function test; Other: Questionnaire for quantifying daytime sleepiness; Other: Questionnaire for recording daytime sleepiness over the course of the day

Study type: Observational

Funder types: Other

Identifiers

NCT04448470

19-002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

130 participants in 2 patient groups

patients with a clinical suspicion of sleep apnea (n=150)

Description:

patients with a clinical suspicion of sleep apnea

Treatment:

Other: Questionnaire for recording daytime sleepiness over the course of the day

Diagnostic Test: Pulmonary function test

Other: Anamnesis and physicial examination

Diagnostic Test: Polygraphy

Other: Questionnaire for quantifying daytime sleepiness

healthy subjects (n=10)

Description:

healthy subjects

Treatment:

Other: Questionnaire for recording daytime sleepiness over the course of the day

Diagnostic Test: Pulmonary function test

Other: Anamnesis and physicial examination

Diagnostic Test: Polygraphy

Other: Questionnaire for quantifying daytime sleepiness