Evaluation of A Morning Dosing Of A New Medicine And Its Effects On Sleep At Bedtime In Subjects With Primary Insomnia
Trial overview
Latency to persistent sleep (LPS), as a mean of PSG recordings obtained on two consecutive nights
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep continuity obtained on two consecutive nights including: Total Sleep Time (TST)
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep continuity obtained on two consecutive nights including: Wake time After Sleep Onset (WASO)
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep continuity obtained on two consecutive nights: WDS
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep continuity obtained on two consecutive nights: WAS
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep continuity obtained on two consecutive nights: number of awakenings during sleep
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep structure: non-REM sleep time
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep structure: Slow-Wave Sleep (SWS) time (Stage 3 and Stage 4)
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep structure: Stage 2 non-REM sleep time
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Objective PSG measures of sleep structure: REM sleep time
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Day time alertness, ability to function and well being of participants assessed by subjective Pre-Sleep Questionnaire to be completed each evening before PSG recording and each evening on Days 3, 4, 5, 6, and 7 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Average of naps taken assessed by subjective Pre-Sleep Questionnaire to be completed each evening before PSG recording and each evening on Days 3, 4, 5, 6, and 7 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Total time spent in napping assessed by subjective Pre-Sleep Questionnaire to be completed each evening before PSG recording and each evening on Days 3, 4, 5, 6, and 7 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Average of alcoholic drinks and caffeinated beverages taken by participants assessed by subjective Pre-Sleep Questionnaire to be completed each evening before PSG recording and each evening on Days 3, 4, 5, 6, and 7 of each double-blind Treatment Period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Number of participants with any food after 7 PM assessed by subjective Pre-Sleep Questionnaire to be completed each evening before PSG recording and each evening on Days 3, 4, 5, 6, and 7 of each treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Subjective Post-Sleep Questionnaire: subjective Sleep Onset Latency (sSOL) to be completed each morning following PSG recording and each morning on Days 4, 5, 6, 7 and 8 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Subjective Post-Sleep Questionnaire: subjective TST (sTST) to be completed each morning following PSG recording and each morning on Days 4, 5, 6, 7 and 8 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Subjective Post-Sleep Questionnaire: subjective WASO (sWaso) to be completed each morning following PSG recording and each morning on Days 4, 5, 6, 7 and 8 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Subjective Post-Sleep Questionnaire: number of awakenings to be completed each morning following PSG recording and each morning on Days 4, 5, 6, 7 and 8 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Subjective Post-Sleep Questionnaire: Sleep Quality (SQ) to be completed each morning following PSG recording and each morning on Days 4, 5, 6, 7 and 8 of each double-blind treatment period
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in day time cognitive function tests (simple reaction time) before and 1 and 3 hours following oral administration of study medication on the Day 1 and 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in day time cognitive function tests (digit vigilance test- target detected) before, and 1 and 3 hours following oral administration of study medication on Day 1 and 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in day time cognitive function tests (digit vigilance test- speed score) before, and 1 and 3 hours following oral administration of study medication on Day 1 and 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in day time cognitive function tests (choice reaction time) before, and 1 and 3 hours following oral administration of study medication on Day 1 and 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in day time cognitive function tests (Bond-Lader visual analogue scale [VAS] of mood and alertness) before, and 1 and 3 hours on Day 1and 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and Up to Day 9 of each treatment period (up to 18 weeks)
Number of participants who passed the Romberg test/heel-to-toe test
Timeframe: Up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) Insomnia Severity Index (ISI) total scores on Day 9 of each treatment period
Timeframe: Baseline (Day 1 pre-dose) and up to Day 9 of each treatment period (up to 18 weeks)
Change from Baseline (Day 1 pre-dose) in ISI item scores at the Day 14 Follow-Up Visit
Timeframe: Baseline (Day 1 pre-dose) and up to Day 14 (up to 18 weeks)
Participation criteria
- Difficulty going to sleep and/or staying asleep during 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, nightshift/rotating shift work, frequent napping or planned travel across >2 time zones.
- Use to moderate use of nicotine, caffeine and alcoholic products.
- Difficulty going to sleep and/or staying asleep during 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.