Transient Insomnia
Conditions
Brief summary
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.
Interventions
DRUGGabapentin
Gabapentin 250 mg oral capsule 30 minutes prior to bedtime for 28 days
DRUGPlacebo
Matched placebo 30 minutes prior to bedtime for 28 days
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Polysomnographic (PSG) measurement of Wake after Persistent Sleep Onset (WAPSO) | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| PSG WAPSO | Day 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 |
| Subjective SL | Days 1 and 28 |
Countries
United States
Outcome results
None listed