Clinical trial NCT04448470: Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sleep-related Respiratory Disorder
Keywords: daytime sleepiness
respiratory disorder
sleep apnea
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2020-06-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Prediction of Sleep Apnea
timeFrame: at Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Düsseldorf
country: Germany
facility: Heinrich-Heine-University
state: North Rhine-Westphalia
city: Neuss
country: Germany
facility: Lung and Allergy Centre
state: North Rhine-Westphalia
Study officials:
affiliation: Heinrich-Heine University, Duesseldorf
name: Malte Kelm, Prof. Dr.
role: STUDY_CHAIR
References: