Healthy Subjects
Conditions
Interventions
Group 1: On 4 study nights, preceded by an evening and followed by a morning, interviews are conducted in the evening and morning, drone or traffic noise are played back and electrophysiological measu
Sponsors
DLR Institut für Luft- und Raumfahrtmedizin, Abteilung Schlaf und Humanfaktoren
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - 18 - 70 years - Male or female - Availability of the signed declarations of consent for data protection (for subject selection and for conducting the study) the subject contract and the subject consent form - Sufficient knowledge of the German language - age-appropriate normal hearing in the frequency range 125 - 8000 Hz - willingness to wear an FFP2 mask during the stay outside the subject rooms and during close contact with study staff (e.g. when applying the electrodes). The obligation to wear an FFP2 mask is currently not provided for and only applies in the event of an aggravated pandemic situation and corresponding recommendations from the DLR crisis unit.
Exclusion criteria
Exclusion criteria: Any medication/disease or disorder/medical treatment/surgery that, could significantly confound the study parameters (especially intrinsic sleep disorders such as restless legs syndrome, periodic limb movement disorder or obstructive sleep apnea syndrome) - BMI > 30 kg/m2 - pregnancy - General consumption of soft and hard drugs - General consumption of nicotine (> 0 rations per day) - Caffeine consumption > 450 mg per day - Alcohol consumption > 14 rations per week - Wearing a hearing aid - Hearing disorders (tinnitus, sudden hearing loss within the last 10 years) or poor hearing, i.e. the hearing thresholds in the worse ear are higher than the 10th percentile of the gender- and age-specific hearing thresholds in ISO 7029 (2017) - Atypical sleeping habits: o on weekdays: going to bed before 9 pm or after 00:00 am, getting up before 5 am or after 8:30 am o Regular sleep duration 9 hours (night sleep time) - Not proficient in the German language - Any other condition that, in the opinion of the doctors conducting the study, makes the subject unsuitable (e.g. claustrophobia, presence of or increased risk of developing a depressive episode due to sleep impairment) - Persons without legal capacity and persons with limited legal capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the probability of a noise-associated awakening. This probability awakening up is determined for drone, road and air traffic as a function of the maximum level of the noise event. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Physiological sleep quality over the entire night (expressed as sleep efficiency, duration of falling asleep, proportion of deep sleep, wake time, number of awakenings) - Characteristics of heart rate variability and blood pressure during sleep and in the morning - Self-assessed sleep quality - Self-assessed sleepiness in the morning - Traffic noise-related annoyance in the morning | — |
Countries
Germany
Contacts
Public ContactSusanne Bartels
DLR Institut für Luft- und Raumfahrtmedizin, Abteilung Schlaf und Humanfaktoren
Outcome results
None listed