Transient Insomnia
Conditions
Brief summary
The purpose of this study is to assess the effect of gabapentin as compared to placebo on sleep, using subjective sleep measurements, in subjects with transient insomnia induced by a sleep phase advance.
Interventions
DRUGGabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime
DRUGPlacebo
Matched placebo 30 minutes prior to bedtime
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective sleep latency | Hour +8 |
Secondary
| Measure | Time frame |
|---|---|
| Subjective assessment of sleep quality | Hour +8 |
| Karolinska Sleep Diary-Sleep (KSD) Quality Index | Hour +8 |
| KSD individual scores | Hour +8 |
| Digit Symbol Substitution Test | Hour +8 |
| Buschke Selective Reminding Test (immediate recall score, long term storage score, total number of intrusions, delayed recall score) | Hour +8 |
| Subjective assessment of sleep refreshment | Hour +8 |
| Vital signs | Hour +8 |
| Adverse events | Hour +13 |
| Subjective number of awakenings | Hour +8 |
| Subjective wake after sleep onset | Hour +8 |
| Subjective total sleep time | Hour +8 |
| Stanford Sleepiness Scale | Hour +13 |
Countries
United States
Outcome results
None listed