Assessment of the reasonableness of sonic booms of planned supersonic commercial or business aircraft.
- Conditions
- healthy subjects
- Registration Number
- DRKS00028595
- Lead Sponsor
- DLRInstitut für Luft- und RaumfahrtmedizinAbteilung Schlaf und Humanfaktoren
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 42
18-65 years
- (sleep) healthy
- Male or female
- normal hearing according to age
- Presence of a signed consent form for data protection, the subject contract, the privacy statement for the conduct of the study and the subject consent form
- sufficient knowledge of the German language
- recovered from COVID-19 (recovered status is not older than 3 months) or completely
vaccinated including booster vaccination (2GPlus rule) or according to the currently
valid Corona protection measures of the DLR
- Willingness to wear an FFP2 mask during the stay outside of the
Willingness to wear a FFP2 mask during the stay outside the study rooms and during close contact with the study personnel according to the currently valid Corona protection measures of the DLR.
- Any medication/disease or disorder/medical treatment/surgery that could, in the
In the opinion of the investigator, could significantly distort the study parameters (especially intrinsic sleep disorders such as Restless Legs Syndrome, Periodic Limb Movement Disorder, or Obstructive Sleep Apnea Syndrome).
- Obesity and overweight with BMI > 30 kg/m2
- Pregnancy
- general use of soft and hard drugs
- general consumption of nicotine
- caffeine consumption > 450 mg per day
- alcohol consumption > 14 rations per week
- hearing disorders (tinnitus, hearing loss) or poor hearing, i.e. hearing thresholds
in an audiometric screening on the worse ear are higher than the 10th
percentile of the gender- and age-specific hearing thresholds in ISO 7029 (2017), there is
an additional malus of 10 dB is considered due to the fact that audiometry does not take place in a sound-isolated room. Since the presented supersonic bangs have a very low frequency range, the audiometric screening only considers frequencies between 125 and 1000 Hz
- Atypical sleep patterns:
(a)Regular sleep duration < 6 and > 9 hours (night sleep time).
b) Sleep times on weekdays: going to bed before 9 p.m. or after 00:00 a.m., getting up before 5 a.m. or after 8:30 a.m.
- not able to speak German
- acute infection with Covid-19
- Any other condition that, in the opinion of the physicians conducting the study, makes the subject unsuitable (e.g. claustrophobia, presence of or increased risk of developing a depressive episode due to impaired
sleep)
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point: the main outcome measure according to the primary hypothesis is the probability (in %) of waking spontaneously or as a result of a sonic boom event.
- Secondary Outcome Measures
Name Time Method Secondary Endpoints: According to the secondary hypotheses, the secondary outcome measures are.<br>- Probability (in %) of spontaneous or supersonic sound event-induced <br>sleep deepening into a shallower sleep stage caused by a sonic boom event. <br>- Probability (in %) of a spontaneous or sonic boom event-induced<br>induced arousal in the EEG<br>- Slow-wave acitivity (SWA) in the EEG of non-REM sleep.<br>- Physiological sleep quality throughout the night (expressed as sleep efficiency, <br>duration of falling asleep, proportion of deep sleep, duration of lying awake, number of awakenings)<br>- Self-assessed sleep quality <br>- Degree of acute annoyance caused by aircraft noise on a scale of 1 and 5<br>- Self-assessed morning sleepiness <br>- Cardiovascular changes expressed as blood pressure and heart rate variability during <br>exposure to sonic boom events during wakefulness