A Polysomnographic Study of Single-Dose 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 assess the effect of gabapentin as compared to placebo on sleep in subjects with transient insomnia.

Official Title
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A Randomized, Double-Blind, Single-Dose, Placebo-Controlled, Multicenter, Polysomnographic Study of Gabapentin 250 mg and 500 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: Gabapentin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged >/= 18 years Females of child-bearing potential using medically-acceptable method of birth control >/= 1 month prior to screening Exclusion Criteria: Current or recent history (within 2 years) of sleep disorder (excessive snoring, obstructive sleep apnea, chronic painful condition) Recreational drug use within past 30 days

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 250 mg<br> | Drug: Gabapentin<br>* Gabapentin 250 mg oral capsule 30 minutes prior to bedtime<br>|
| Experimental: Gabapentin 500 mg<br> | Drug: Gabapentin<br>* Gabapentin 500 mg oral capsule 30 minutes prior to bedtime<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matched placebo 30 minutes prior to bedtime<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency to persistent sleep as measured by polysomnography |  | Hour +8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective wake after sleep onset |  | Hour +8 | 
| Subjective total sleep time |  | Hour +8 | 
| Subjective assessment of sleep refreshment |  | Hour +8 | 
| Subjective assessment of sleep quality |  | Hour +8 | 
| Stanford Sleepiness Scale |  | Hour +13 | 
| Karolinska Sleep Diary-Sleep (KSD) Quality Index |  | Hour +8 | 
| KSD individual scores |  | Hour +8 | 
| Digit Symbol Substitution Test |  | Hour +8 | 
| Latency to REM sleep |  | Hour +8 | 
| Number of awakenings |  | Hour +8 | 
| Wake after sleep onset |  | Hour +8 | 
| Total wake time plus Stage 1 sleep |  | Hour +8 | 
| Total sleep time |  | Hour +8 | 
| Sleep efficiency |  | Hour +8 | 
| Percent of Stages 1, 2, 3, 4 (non-REM) and REM sleep |  | Hour +8 | 
| Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) |  | Hour +8 | 
| Vital signs |  | Hour +8 | 
| Adverse events |  | Hour +13 | 
| Sleep onset latency |  | Hour +8 | 
| Percent slow wave sleep (Stages 3&4 combined) |  | Hour +8 | 
| Subjective sleep latency |  | Hour +8 | 
| Subjective number of awakenings |  | Hour +8 |