A 28-Day Polysomnographic Study of Gabapentin in Transient Insomnia Induced by a Sleep Phase Advance

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Double-Blind, Placebo-Controlled, Multicenter, 28-day, Polysomnographic Study of Gabapentin 250 mg in Transient Insomnia Induced by a Sleep Phase Advance

Conditions
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Transient Insomnia

Intervention / Treatment
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* Drug: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older with occasional sleeplessness in the month prior to screening Exclusion Criteria: Current treatment for, or recent history (within 2 years) of, a sleeping disorder including excessive snoring, obstructive sleep apnea or a chronic painful condition that interferes with the subject's sleep Currently taking or expected to take any of the following during trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbiturates, and phencyclidine during their participation in the trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gabapentin<br> | Drug: Gabapentin<br>* Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matched placebo 30 minutes prior to bedtime for 28 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSG WAPSO |  | Day 28 | 
| PSG Latency to Persistent Sleep (LPS) |  | Days 1 and 28 | 
| PSG Sleep Onset Latency (SOL) |  | Days 1 and 28 | 
| PSG Number of Awakenings (NAW) |  | Days 1 and 28 | 
| PSG Wake after Sleep Onset (WASO) |  | Days 1 and 28 | 
| PSG Total Wake Time (TWT) plus Stage 1 Sleep |  | Days 1 and 28 | 
| PSG Wake Time During Sleep (WTDS) |  | Days 1 and 28 | 
| PSG Total Sleep Time (TST) |  | Days 1 and 28 | 
| PSG Sleep Efficiency (SE) |  | Days 1 and 28 | 
| PSG Percent of Stages 1, 2, 3, 4 and REM sleep |  | Days 1 and 28 | 
| PSG Percent Slow Wave Sleep (SWS, Stages 3&4 combined) |  | Days 1 and 28 | 
| Subjective SL |  | Days 1 and 28 | 
| Subjective NA |  | Days 1 and 28 | 
| Subjective WASO |  | Days 1 and 28 | 
| Subjective TST |  | Days 1 and 28 | 
| Subjective ASR |  | Days 1 and 28 | 
| Subjective ASQ |  | Days 1 and 28 | 
| Karolinska Sleep Diary (KSD)-Sleep Quality Index |  | Days 1 and 28 | 
| KSD individual scores |  | Days 1 and 28 | 
| Vital signs |  | Days 1 and 28 | 
| Adverse events |  | Through Day 32 |