Sleep Clinical Trial
to develop the maximally effective treatment strategy for chronic sleep-onset insomnia and to reduce its impact on psychological functioning, health, and economic sequelae.
DESIGN NARRATIVE:
The study examined the relative efficacy of a pharmacologic, cognitive behavioral, and
conjoint pharmacological/behavioral intervention for chronic sleep-onset insomnia.
Sixty-three medication-free, chronic sleep-onset insomniacs completed evaluations, baseline
sleep diaries, daytime functioning and mood inventories and home-based objective sleep
assessments (OSA). Subjects were then randomized to one of four interventions: 1) six week
Zolpidem intervention (D for drug); 2) six week multifactor behavioral intervention (B for
behavioral); 3) six week conjoint Zolpidem and multifactor behavioral intervention (DB); and
4) placebo medication intervention (P for placebo). The main outcome measures were
sleep-onset latency as measured by sleep diaries; secondary measures included sleep diary
measures of sleep efficiency and total sleep time, objective measures of sleep variables
(Nightcap sleep monitor recorder), and measures of daytime functioning.
The study completion date listed in this record was obtained from the "End Date" entered in
the Protocol Registration and Results System (PRS) record.
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