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

• Conditions: Sleep-related Respiratory Disorder
• Interventions: 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

• Registration Number: NCT04448470
• Lead Sponsor: 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.

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 Timeline

• Status Verified: 2020-06
• Study Start: 2020-06-24
• Study First Submitted: 2020-06-24
• Study First Submitted QC: 2020-06-24
• Last Update Submitted: 2020-06-24
• Study First Posted: 2020-06-25
• Last Update Posted: 2020-06-25
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients with a clinical suspicion of sleep apnea (n=150)	Questionnaire for recording daytime sleepiness over the course of the day	patients with a clinical suspicion of sleep apnea
patients with a clinical suspicion of sleep apnea (n=150)	Anamnesis and physicial examination	patients with a clinical suspicion of sleep apnea
patients with a clinical suspicion of sleep apnea (n=150)	Pulmonary function test	patients with a clinical suspicion of sleep apnea
healthy subjects (n=10)	Questionnaire for recording daytime sleepiness over the course of the day	healthy subjects
patients with a clinical suspicion of sleep apnea (n=150)	Questionnaire for quantifying daytime sleepiness	patients with a clinical suspicion of sleep apnea
healthy subjects (n=10)	Anamnesis and physicial examination	healthy subjects
healthy subjects (n=10)	Pulmonary function test	healthy subjects
healthy subjects (n=10)	Polygraphy	healthy subjects
patients with a clinical suspicion of sleep apnea (n=150)	Polygraphy	patients with a clinical suspicion of sleep apnea
healthy subjects (n=10)	Questionnaire for quantifying daytime sleepiness	healthy subjects

Primary Outcome Measures

Name	Time	Method
Prediction of Sleep Apnea	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

Trial Locations

Locations (2)

Lung and Allergy Centre; 🇩🇪 Neuss, North Rhine-Westphalia, Germany

Heinrich-Heine-University; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany