Coordinated autonomous ground-to-air systems for a new rescue mobility (KoBoL)Substudy to assess the potential for sleep disturbance and annoyance due to drone traffic
- Conditions
- Healthy Subjects
- Registration Number
- DRKS00034072
- Lead Sponsor
- DLR Institut für Luft- und Raumfahrtmedizin, Abteilung Schlaf und Humanfaktoren
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
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.
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 < 6 and > 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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>
- Secondary Outcome Measures
Name Time Method - Physiological sleep quality over the entire night (expressed as sleep efficiency, <br> duration of falling asleep, proportion of deep sleep, wake time, number of <br> awakenings)<br> - Characteristics of heart rate variability and blood pressure during sleep and <br> in the morning <br>- Self-assessed sleep quality <br>- Self-assessed sleepiness in the morning<br> - Traffic noise-related annoyance in the morning<br><br>