The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
377
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
Gabapentin 500 mg oral capsule 30 minutes prior to bedtime
Matched placebo oral capsule 30 minutes prior to bedtime
Pfizer Investigational Site
Miami, Florida, United States
Pfizer Investigational Site
Atlanta, Georgia, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Pfizer Investigational Site
Cincinnati, Ohio, United States
Wake after sleep onset as measured by polysomnography (PSG)
Time frame: Hour +8
PSG Latency to Persistent Sleep
Time frame: Hour +8
PSG Wake Time During Sleep
Time frame: Hour +8
PSG WASO
Time frame: Hour +8
PSG Sleep Onset Latency
Time frame: Hour +8
Vital signs
Time frame: Hour +8
Karolinska Sleep Diary-Sleep (KSD) Quality Index
Time frame: Hour +8
KSD individual scores
Time frame: Hour +8
PSG NA
Time frame: Hour +8
Adverse events
Time frame: Hour +13
PSG Total wake time plus Stage 1 sleep
Time frame: Hour +8
PSG TST
Time frame: Hour +8
PSG Sleep Efficiency
Time frame: Hour +8
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PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time frame: Hour +8
PSG Percent slow wave sleep (Stages 3&4 combined)
Time frame: Hour +8
subjective Sleep Latency
Time frame: Hour +8
subjective Number of Awakenings (NA)
Time frame: Hour +8
subjective Wake After Sleep Onset (WASO)
Time frame: Hour +8
subjective Total Sleep Time (TST)
Time frame: Hour +8
subjective Assessment of Sleep Refreshment
Time frame: Hour +8
subjective Assessment of Sleep Quality
Time frame: Hour +8