healthy volunteers
Conditions
Interventions
Group 1: Subjects will be exposed with acoustic irradiation up to 85 dB in maximum exactly within the deep sleep phase.
Sponsors
Atral-Secal GmbH
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: age = 18 and = 65 years; willingness to spend two nights in a sleep laboratory; signed informed consent form
Exclusion criteria
Exclusion criteria: • Subjects not able to self-rescue in the context of the trial (psychological or medical conditions that would jeopardise an adequate completion of the trial like e.g. no sole sit up and wave/press a bottom/speak is possible) • Visible sleep disturbances within the screening night (e.g. no reach of deep sleep phase) • From ENT physician diagnosed hardness of hearing (exception of age-related hardness of hearing) • Using of sleeping aids (e.g. earplugs, sleeping stimulating substances, restricting reactive capacities in judgment of the investigator) • Known intake of test substances in the context of clinical trials (within 5 half-lives prior baseline)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non-awake as a function of sound intensity of healthy volunteers will be investigated as a curve using the continual reassessment method (CRM). (Wake up (yes/no) after start of sounding on intervention night). | — |
Secondary
| Measure | Time frame |
|---|---|
| Time until awake will be analysed. (Are there differences due to awake between polysomnogram and complex action?). Furthermore it will be tested if there are differences with regard to sex, age and if applicable hearing. | — |
Countries
Germany
Contacts
Public ContactChristine Peréz-Hadel
Klinische Forschung Hannover-Mitte GmbH
Outcome results
None listed