Sleep-related Respiratory DisorderNCT04448470
Daytime Sleepiness in Patients With the Assessment of a Sleep-related Respiratory Disorder
An observational study of Sleep-related Respiratory Disorder, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep-related Respiratory Disorder
- What is being tested?
- Questionnaire for recording daytime sleepiness over the course of the day, Anamnesis and physicial examination and Questionnaire for quantifying daytime sleepiness
- How many people
- 130 participants
- Where
- 2 sitesGermany
- Study dates
- 24 Jun 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Lack of consent to participate in the study
- Pregnancy and breast feeding period
- Lack of willingness and ability to participate in the study
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Heinrich-Heine-University
Düsseldorf, North Rhine-Westphalia, 40225
Stefanie Keymel, MD, +492118118800, ctsu@med.uni-duesseldorf.de
Rabea Wagstaff, M.A., ctsu@med.uni-duesseldorf.de
- Recruiting
Lung and Allergy Centre
Neuss, North Rhine-Westphalia, 41462
Johannes Uerscheln, MD
Johannes Uerscheln, MD
About this study
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
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.
Read the 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:
- 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?
- Is there a relation between the degree of the scale based psychometric time series test for daytime sleepiness and the severity of sleep apnea?
- 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
- Being tested
- Questionnaire for recording daytime sleepiness over the course of the day, Anamnesis and physicial examination, Questionnaire for quantifying daytime sleepiness, Pulmonary function test, Polygraphy
- Keywords
- daytime sleepiness, respiratory disorder, sleep apnea
- Medical subject headings
- Disorders of Excessive Somnolence, Respiration Disorders, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire for recording daytime sleepiness over the course of the dayOther
Questionnaire for recording daytime sleepiness over the course of the day
Anamnesis and physicial examinationOther
Anamnesis and physical examination, e.g. medication, comorbidities, complaints
Questionnaire for quantifying daytime sleepinessOther
the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire
Pulmonary function testDiagnostic test
The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.
PolygraphyDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| patients with a clinical suspicion of sleep apnea (n=150) | patients with a clinical suspicion of sleep apnea Receives: 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 | |
| healthy subjects (n=10) | healthy subjects Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prediction of Sleep Apnea
the degree of daytime sleepiness can predict the presence of sleep apnea the degree of daytime sleepiness can predict the presence of sleep apnea
Measured: at Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start24 Jun 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep-related Respiratory DisorderStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
- Investigators
- Malte Kelm, Prof. Dr., Study chair, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04448470
- Sponsor's protocol ID
- 19-002
- Status last verified
- Jun 2020
- First submitted
- 24 Jun 2020
- Last updated
- 25 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04448470
- Acronym / sponsor ID
- 19-002
- Conditions
- Sleep-related Respiratory Disorder
- Keywords
- daytime sleepiness, respiratory disorder, sleep apnea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 24 Jun 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 25 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- Is there a relation between the degree of the scale based psychometric time series test for daytime sleepiness and the severity of sleep apnea?
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a clinical suspicion of sleep apnea (n=150) | – | 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: Polygraphypatients with a clinical suspicion of sleep apnea |
| healthy subjects (n=10) | – | 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: Polygraphyhealthy subjects |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire for recording daytime sleepiness over the course of the dayQuestionnaire for recording daytime sleepiness over the course of the day | Other | healthy subjects (n=10), patients with a clinical suspicion of sleep apnea (n=150) |
| Anamnesis and physicial examinationAnamnesis and physical examination, e.g. medication, comorbidities, complaints | Other | healthy subjects (n=10), patients with a clinical suspicion of sleep apnea (n=150) |
| Questionnaire for quantifying daytime sleepinessthe Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire | Other | healthy subjects (n=10), patients with a clinical suspicion of sleep apnea (n=150) |
| Pulmonary function testThe measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available. | Diagnostic test | healthy subjects (n=10), patients with a clinical suspicion of sleep apnea (n=150) |
| PolygraphyPolygraphy 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. | Diagnostic test | healthy subjects (n=10), patients with a clinical suspicion of sleep apnea (n=150) |
Primary outcome
Prediction of Sleep Apnea
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Malte Kelm, Prof. Dr. study chair
Heinrich-Heine University, Duesseldorf
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep-related Respiratory Disorder, run by Heinrich-Heine University, Duesseldorf at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefanie Keymel, MD (+492118118800, ctsu@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prediction of Sleep Apnea (time frame: at Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.