healthy subjects F51.0
Conditions
Interventions
Group 1: Study participants receive a home sleep measurement for 3 consecutive nights
Sponsors
SOMNOmedics AG
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: - patients with suspicion of primary insomnia or - healthy people without sleep disorders based anamnesis
Exclusion criteria
Exclusion criteria: - patients with suspected or known existing other sleep disorders (e. g. OSA, PLM) - patients with pimary insomnia receiving drug therapy - participation in clinical pharmacological trials 4 weeks before the start of the study - known or acute psychiatric / neurological illnesses or mental disorders occurring during the study that impair compliance - significant cardiovascular, gastrointestinal, or malignant diseases that require medical treatment - drug use, alcohol abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Distribution of EEG power spectra from 8-hours home electrophysiological sleep measurement | — |
Secondary
| Measure | Time frame |
|---|---|
| - variability of measured sleep structure in the course of three consecutive nights - correlation of measured sleep structure with anamnestic data on sleep behavior and of sleep structurestructure - correlation of EEG power spectrum with sleep structure parameters according to the manual of the American Academy of Sleep Medicine (AASM) | — |
Countries
Germany
Contacts
Public ContactIngo Fietze
Charité-Universitätsmedizin Berlin
Outcome results
None listed