Primary Insomnia Clinical Trial
Official title:
Phase II Study of Sleep Inducing And Maintaining Efficacy Of Circadin In Elderly Insomniacs.
The aim of this placebo controlled study is to investigate the effect of 2 mg melatonin Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55 years or more.
Circadin® is a newly developed slow release galenic formulation of melatonin, producing
overall levels of melatonin comparable to those observed in a control population, when
administered to patients with deficiency in melatonin; thus it deserves more clinical and
paraclinical investigations for establishing efficacy in inducing and maintaining sleep and
for safety. Since, on the one hand, the endogenous substance melatonin has beneficial
effects on sleep in man and, on the other hand, there is a decrease in melatonin secretion
in elderly people, substitution therapy in elderly insomniacs would be a desirable therapy.
The aim of this placebo controlled study was to investigate the effect of 2 mg Melatonin
Slow Release (Circadin®) on the sleep/wake cycle in elderly insomniac out-subjects, aged 55
years or more. Sleep was assessed by means of polysomnography (hypnographic results),
all-night sleep EEG spectral analysis (functional and quantitative results of sleep EEG),
actimetry (SomnitorTM), wake EEG and sleep/wake quality questionnaires. Vigilance and
cognitive skills were assessed by means of psychomotor and neurocognitive tests derived from
the Leeds psychomotor test battery (vigilance and arousal) and TEA battery (attention).
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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