Effects Of GW679769 On Sleep Onset And Maintenance,And Next Day Functioning In The Elderly And Non-elderly With Primary Insomnia
Trial overview
Latency to persistent sleep (LPS), as mean of PSG recordings obtained on two consecutive nights
Timeframe: Nights 1 and 2 of each treatment period (up to approximately 64 days)
Mean Total Sleep Time (TST) as objective PSG measures of sleep continuity.
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Mean wake time after persistent sleep onset (WASO1) as objective PSG measures of sleep continuity.
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Mean wake during sleep (WDS) as objective PSG measures of sleep continuity
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Mean Wake after sleep (WAS) as Objective PSG measures of sleep continuity
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Mean number of awakenings during sleep (NAASO) as Objective PSG measures of sleep continuity
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Mean Non-Rapid Eye Movement (NREM) sleep time as objective PSG measures of sleep structure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Slow-Wave Sleep (SWS) time (stage 3 and 4) as objective PSG measures of sleep structure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Stage 2 non-REM sleep time (ST2) as objective PSG measures of sleep structure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
REM sleep time as objective PSG measures of sleep structure.
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
REM activity as objective PSG measures of sleep structure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
REM density as objective PSG measures of sleep structure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Sleep onset latency (sSOL) as subjective post-sleep measure
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Mean sTST as subjective post-sleep measure
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
sWASO as subjective post-sleep measure
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Number of awakenings as subjective post-sleep measure
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Mean sleep quality completed each morning as subjective post-sleep measure.
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Mean Morning Sleepiness Scores as subjective post-sleep measure
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Mean daytime alertness as subjective pre-sleep measure
Timeframe: Nights 1 and 2 of each treatment period (Approximately up to 64 days)
Number of participants with daytime naps as subjective pre-sleep measure at Day 1 and Day 2.
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Digit Symbol Substitution Test (DSST) Score as daytime cognitive function tests on the morning following PSG recording.
Timeframe: Days 1 and 2 of each treatment period (Approximately up to 64 days)
Hopkins Verbal Learning Test (HVLT-R) as daytime cognitive function tests on the morning following PSG recording
Timeframe: Day 2 of each treatment period (Approximately up to 64 days)
Participation criteria
- Difficulty going to sleep and/or staying asleep for at least the past 3 months.
- Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
- History of other sleep disorders such as sleep apnea or restless leg syndrome.
- Regular sleep habits, including bedtime between 9 PM and midnight.
- Difficulty going to sleep and/or staying asleep for at least the past 3 months.
- Insomnia must result in significant distress or impairment in functioning at home, socially or at work.
- Otherwise good health with no significant or unstable medical disorder including psychiatric, neurological, endocrine, heart, lung or gastrointestinal disorders, drug/alcohol abuse, cognitive impairment, cancer or chronic pain conditions such as arthritis.
- History of other sleep disorders such as sleep apnea or restless leg syndrome.
- Regular sleep habits, including bedtime between 9 PM and midnight.
- Nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
- Use to moderate use of nicotine, caffeine and alcoholic products.
Trial location(s)
Study documents
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.