Measurements in functional sleep
disturbances
Usefulness of the methods
To determine the characteristic features of a new
hypnotic in patients is difficult, often frustrating, time consuming and expensive
as sleep disturbances in patients are often symptoms of other diseases which
cause non-homogeneity of the study groups and require concomitant specific therapy
which interferes with drug testing.
In our approach functional sleep disturbances
are initiated by a shift from night sleep to day sleep or vice versa.. Using
these disorders of sleep for drug testing is not only free of the problems described
above but is in addition close to the practical clinical situation (night shift
work, jet lag) in which hypnotics may be indicated. In this situation the effect
of hypnotics and sleep inducers and other drugs on duration and quality of sleep
can be meaningfully tested.
Principle of the methods
Night sleepers are investigated after a night awake during the following day. As a reference the normal night sleep is recorded. The subjects are investigated in noise protected, dark, air-conditioned rooms. During sleep the following parameters will be recorded: EEG ( bipolar O2 - Cz ), bipolar EOG and bipolar, sub-mental EMG for sleep stage analysis (polysomnography). In addition the following parameters are recorded and evaluated: latency to sleep, duration of sleep, proportion of the sleep stages 1-6 in total sleep, latency to REM, number of REM cycles. Combination with our test battery investigating vigilance and performance provides data on the presence or absence of a hang over following the sleep period.
Advantages of the methods
The functional sleep disturbances induced by a shift
in the sleeping time are much more uniform than sleep disorders in patients
with multimorbidity.
The parameters of the individual normal sleep are recorded so that each subject
serves as his own control.
The very high intra-individual reproducibility allows for cross over designs.
Reference data
Data are available for benzodiazepine and non- benzodiazepine hypnotics.
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