Healthy Volunteers F51.0
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • healthy volunteers with respect to sleep and hearing capability
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sleep efficacy [%] based on polysomnography which is performed on three locations for one night (duration 8 hours) each, calculation: (total sleep time [min] / total bed time [min]) * 100 [%] | — |
Secondary
| Measure | Time frame |
|---|---|
| - total sleep time [min], asleep latency [min], number of arousal, and percentage of sleep stages on total sleep time [%]; all variables based on polysomnography which is performed on three locations for one night (duration 8 hours) each, - self rating scale for sleep quality (VIS-M) | — |
Countries
Germany
Contacts
Charité- Universitätsmedizin Berlin, CCM-CC11, Interdisziplinäres Schlafmedizinisches Zentrum