Insomnia
Conditions
Keywords
Insomnia, Primary Insomnia, Chronic Insomnia, DIMS (Disorders of Initiating and Maintaining Sleep), Disorders of Initiating and Maintaining Sleep
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter trial with a 4-way crossover design. Elderly subjects with primary insomnia who meet screening requirements will initially be randomized into the study and receive the first of 4 treatments (PD 0200390 5 mg, 15 mg and 30 mg or placebo) daily 30 minutes before bed time for 2 consecutive days in a polysomnography (PSG) lab.
Interventions
DRUGPlacebo
Subjects in this arm will be administered 3 capsules of placebo 30 minutes before bedtime for two consecutive nights in the sleep lab.
DRUGPD 0200390
Subjects in this arm will be administered 3 capsules totaling 5 milligrams 30 minutes before bedtime for two consecutive nights in the sleep lab.
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 3 month history of primary insomnia * Difficulty initiating and maintaining sleep for at least 3 nights/week for the past month (difficulty falling asleep, difficulty staying asleep, early awakening)
Exclusion criteria
* Any history of psychiatric diagnosis * History or presence of any breathing related sleep disorder * History or presence of any medical or neurological condition that could interfere with sleep * Use of alcohol as a sleep aid or more than 2 standard drinks consumed per day or more than 14 consumed per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wake After Sleep Onset (WASO) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
Secondary
| Measure | Time frame |
|---|---|
| Latency to persistent sleep (LPS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Latency to REM Sleep as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Sleep efficiency (SE) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Number of awakenings after sleep onset (NAASO) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Total wake time (TWT) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Next day sleepiness as determined by Visual Analog Scale (VAS) for Sleepiness | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Number of arousals as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Sleep and early morning behavior as determined by Leeds Sleep Evaluation Questionnaire (LSEQ) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Next day performance sa determined by Digit Symbol Substitution Test (DSST) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Subjective Sleep Onset and Maintenance as determined by Subjective Sleep Questionnaire (SSQ) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Wake time during sleep (WTDS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Wake time after sleep (WTAS) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Percentages of Stage 1 Sleep, Stage 2 Sleep, Stage 3+4 Sleep, Stage REM Sleep as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
| Restorative sleep as determined by Restorative Sleep Questionnaire Daily (RSQ D) | Days -6, -5, 2, 3, 9, 10, 16, 17, 23, and 24 |
| Total sleep time (TST) as determined by PSG assessment | Days -7, -6, 1, 2, 8, 9, 15, 16, 22, and 23 |
Outcome results
None listed