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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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04448470
Enrollment
130
Registered
2020-06-25
Start date
2020-06-24
Completion date
2021-06-30
Last updated
2020-06-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep-related Respiratory Disorder

Keywords

daytime sleepiness, respiratory disorder, sleep apnea

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.

Interventions

OTHERQuestionnaire for recording daytime sleepiness over the course of the day

Questionnaire for recording daytime sleepiness over the course of the day

OTHERAnamnesis and physicial examination

Anamnesis and physical examination, e.g. medication, comorbidities, complaints

OTHERQuestionnaire for quantifying daytime sleepiness

the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire

DIAGNOSTIC_TESTPulmonary function test

The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.

DIAGNOSTIC_TESTPolygraphy

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.

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Prediction of Sleep Apneaat Baselinethe degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea

Countries

Germany

Contacts

Primary ContactStefanie Keymel, MD
ctsu@med.uni-duesseldorf.de+492118118800
Backup ContactRabea Wagstaff, M.A.
ctsu@med.uni-duesseldorf.de+492118118914

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026