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

NCT ID: NCT04448470

Last Updated: 2020-06-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-24
• Study Completion Date: 2021-06-30

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.

Conditions

Sleep-related Respiratory Disorder

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

patients with a clinical suspicion of sleep apnea

Questionnaire for recording daytime sleepiness over the course of the day

Intervention Type: OTHER

Questionnaire for recording daytime sleepiness over the course of the day

Anamnesis and physicial examination

Intervention Type: OTHER

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

Questionnaire for quantifying daytime sleepiness

Intervention Type: OTHER

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

Pulmonary function test

Intervention Type: DIAGNOSTIC_TEST

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

Polygraphy

Intervention Type: DIAGNOSTIC_TEST

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.

healthy subjects (n=10)

healthy subjects

Questionnaire for recording daytime sleepiness over the course of the day

Intervention Type: OTHER

Questionnaire for recording daytime sleepiness over the course of the day

Anamnesis and physicial examination

Intervention Type: OTHER

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

Questionnaire for quantifying daytime sleepiness

Intervention Type: OTHER

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

Pulmonary function test

Intervention Type: DIAGNOSTIC_TEST

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

Polygraphy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

Questionnaire for recording daytime sleepiness over the course of the day

Questionnaire for recording daytime sleepiness over the course of the day

Intervention Type: OTHER

Anamnesis and physicial examination

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

Intervention Type: OTHER

Questionnaire for quantifying daytime sleepiness

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

Intervention Type: OTHER

Pulmonary function test

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

Intervention Type: DIAGNOSTIC_TEST

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age 18-80 years
• Written informed consent to participate in this study
• Patients with a clinical suspicion of sleep apnea

• 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

• 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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Principle Investigator Dr. Stefanie Keymel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malte Kelm, Prof. Dr.

Role: STUDY_CHAIR

Heinrich-Heine University, Duesseldorf

Locations

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Lung and Allergy Centre

Neuss, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Stefanie Keymel, MD

Role: CONTACT

ctsu@med.uni-duesseldorf.de

+492118118800

Rabea Wagstaff, M.A.

Role: CONTACT

ctsu@med.uni-duesseldorf.de

+492118118914

Facility Contacts

Stefanie Keymel, MD

Role: primary

ctsu@med.uni-duesseldorf.de

+492118118800

Rabea Wagstaff, M.A.

Role: backup

ctsu@med.uni-duesseldorf.de

Johannes Uerscheln, MD

Role: primary

Other Identifiers

19-002

Identifier Type: -

Identifier Source: org_study_id