Evaluation of sound intensity necessary for waking up out of deep sleep phase

Not Applicable

• Conditions: healthy volunteers

• Registration Number: DRKS00016672
• Lead Sponsor: Atral-Secal GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-16
• Study Completion: 2020-01-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 101

Inclusion Criteria

age = 18 and = 65 years; willingness to spend two nights in a sleep laboratory;
signed informed consent form

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)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
on-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 Outcome Measures

Name	Time	Method
Time until awake will be analysed. (Are there differences due to awake between polysomnogram and complex action?).<br>Furthermore it will be tested if there are differences with regard to sex, age and if applicable hearing.