A Polysomnographic Study Of Single-Dose Gabapentin In Transient Insomnia

Study Overview
=================
Brief Summary
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The purpose of this study is to assess the effect of gabapentin on polysomnographic assessments in transient insomnia induced by a sleep phase advance.

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 who reported occasional sleeplessness in the month prior to screening 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) Currently taking or expected to take any of the following during the trial: amphetamines, benzodiazepines, cocaine, marijuana, methaqualone, methadone, opiates, propoxyphene, barbituates, and phencyclidine

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wake after sleep onset as measured by polysomnography (PSG) |  | Hour +8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PSG Latency to Persistent Sleep |  | Hour +8 | 
| PSG Wake Time During Sleep |  | Hour +8 | 
| PSG WASO |  | Hour +8 | 
| PSG Sleep Onset Latency |  | Hour +8 | 
| Vital signs |  | Hour +8 | 
| Karolinska Sleep Diary-Sleep (KSD) Quality Index |  | Hour +8 | 
| KSD individual scores |  | Hour +8 | 
| PSG NA |  | Hour +8 | 
| Adverse events |  | Hour +13 | 
| PSG Total wake time plus Stage 1 sleep |  | Hour +8 | 
| PSG TST |  | Hour +8 | 
| PSG Sleep Efficiency |  | Hour +8 | 
| PSG Percent of Stages 1, 2, 3, 4 and REM sleep |  | Hour +8 | 
| PSG Percent slow wave sleep (Stages 3&4 combined) |  | Hour +8 | 
| subjective Sleep Latency |  | Hour +8 | 
| subjective Number of Awakenings (NA) |  | Hour +8 | 
| subjective Wake After Sleep Onset (WASO) |  | Hour +8 | 
| subjective Total Sleep Time (TST) |  | Hour +8 | 
| subjective Assessment of Sleep Refreshment |  | Hour +8 | 
| subjective Assessment of Sleep Quality |  | Hour +8 |