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

NCT04448470 | Unknown

• 1 other identifier: 19-002
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 2

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.

Conditions

Sleep-related Respiratory Disorder

Keywords

daytime sleepiness; respiratory disorder; sleep apnea

Outcome Measures

Primary Outcomes (1)

• 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

  at Baseline

Study Arms (2)

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

patients with a clinical suspicion of sleep apnea

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

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

Interventions

Questionnaire for recording daytime sleepiness over the course of the day OTHER

Questionnaire for recording daytime sleepiness over the course of the day

healthy subjects (n=10); patients with a clinical suspicion of sleep apnea (n=150)

Anamnesis and physicial examination OTHER

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

healthy subjects (n=10); patients with a clinical suspicion of sleep apnea (n=150)

Questionnaire for quantifying daytime sleepiness OTHER

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

healthy subjects (n=10); patients with a clinical suspicion of sleep apnea (n=150)

Pulmonary function test DIAGNOSTIC_TEST

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

healthy subjects (n=10); patients with a clinical suspicion of sleep apnea (n=150)

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

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead

Study Sites (2)

Heinrich-Heine-University

Düsseldorf, North Rhine-Westphalia, 40225, Germany

RECRUITING

Lung and Allergy Centre

Neuss, North Rhine-Westphalia, 41462, Germany

RECRUITING

MeSH Terms

Conditions

Disorders of Excessive Somnolence; Respiration Disorders; Sleep Apnea Syndromes

Interventions

Surveys and Questionnaires; Immunologic Memory; Respiratory Function Tests

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Respiratory Tract Diseases; Apnea

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Adaptive Immunity; Immunity; Immune System Phenomena; Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Malte Kelm, Prof. Dr.

  Heinrich-Heine University, Duesseldorf

  STUDY CHAIR

Central Study Contacts

Stefanie Keymel, MD

CONTACT

+492118118800; ctsu@med.uni-duesseldorf.de

Rabea Wagstaff, M.A.

CONTACT

+492118118914; ctsu@med.uni-duesseldorf.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator Dr. Stefanie Keymel

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 25, 2020
• Study Start: June 24, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: June 25, 2020

Record last verified: 2020-06

Locations

DE (2)