The purpose of this study is to to assess the effect of gabapentin compared to placebo on sleep, using polysomnography along with subjective sleep assessments, in subjects with transient insomnia induced by a sleep phase advance.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
256
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
Matched placebo 30 minutes prior to bedtime for 28 days
Pfizer Investigational Site
Glendale, California, United States
Pfizer Investigational Site
San Diego, California, United States
Pfizer Investigational Site
Overland Park, Kansas, United States
Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO)
Time frame: Day 1
PSG WAPSO
Time frame: Day 28
PSG Latency to Persistent Sleep (LPS)
Time frame: Days 1 and 28
PSG Sleep Onset Latency (SOL)
Time frame: Days 1 and 28
PSG Number of Awakenings (NAW)
Time frame: Days 1 and 28
PSG Wake after Sleep Onset (WASO)
Time frame: Days 1 and 28
PSG Total Wake Time (TWT) plus Stage 1 Sleep
Time frame: Days 1 and 28
PSG Wake Time During Sleep (WTDS)
Time frame: Days 1 and 28
PSG Total Sleep Time (TST)
Time frame: Days 1 and 28
PSG Sleep Efficiency (SE)
Time frame: Days 1 and 28
PSG Percent of Stages 1, 2, 3, 4 and REM sleep
Time frame: Days 1 and 28
PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined)
Time frame: Days 1 and 28
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Subjective SL
Time frame: Days 1 and 28
Subjective NA
Time frame: Days 1 and 28
Subjective WASO
Time frame: Days 1 and 28
Subjective TST
Time frame: Days 1 and 28
Subjective ASR
Time frame: Days 1 and 28
Subjective ASQ
Time frame: Days 1 and 28
Karolinska Sleep Diary (KSD)-Sleep Quality Index
Time frame: Days 1 and 28
KSD individual scores
Time frame: Days 1 and 28
Vital signs
Time frame: Days 1 and 28
Adverse events
Time frame: Through Day 32