The effect of room acoustics on the sleep quality of healthy sleepers

Not Applicable

• Conditions: Healthy Volunteers; F51.0; Nonorganic insomnia

• Registration Number: DRKS00007827
• Lead Sponsor: Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2011-06-03
• Study Start: 2015-02-24
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• healthy volunteers with respect to sleep and hearing capability

Exclusion Criteria

•loss of hearing (confirmed by audiometry)
•Apnea Hypopnea Index (AHI) > 10/h
•Restless Legs Syndrome (RLS)/ Periodic Limb Movement Disorder (PLMD)
•Periodic Limb Movement Index (PLMI) > 10/h
•episodes of pain during the night
•Questionnaire ESS > 10
•Questionnaire PSQI > 5
•Questionnaire ISI > 10
•relevant heart circulatory diseases
•relevant psychiatric diseases
•relevant neurological diseases
•drug intake during the study
•alcohol dependency
•drug abusus
•irregular sleep wake rhythm ( e.g. shift work)
•participation in a clinical trial up to 4 weeks before entering the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
sleep efficacy [%] based on polysomnography which is performed on three locations for one night (duration 8 hours) each,<br>calculation: (total sleep time [min] / total bed time [min]) * 100 [%]

Secondary Outcome Measures

Name	Time	Method
- total sleep time [min], asleep latency [min], number of arousal, and percentage of sleep stages on total sleep time [%];<br>all variables based on polysomnography which is performed on three locations for one night (duration 8 hours) each,<br>- self rating scale for sleep quality (VIS-M)