Sleep Initiation and Maintenance Disorders
Conditions
Keywords
primary insomnia, PSG sleep recordings, daytime cognitive function, Insomnia, SB-649868
Brief summary
This study to evaluate the effects of SB-649868 (10, 30 mg and 60 mg) on sleep continuity, PSG sleep recordings, subjective sleep assessment, and daytime cognitive function in subjects with primary insomnia
Interventions
DRUGSB-649868
Active compound at doses of 10mg, 30mg and 60mg
DRUGPlacebo
Placebo to match SB-649868
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
MALE
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Male * 18-64 years of age (inclusive), * Diagnosis of primary insomnia who have had symptoms for at least three months.
Exclusion criteria
* Any clinically significant unstable medical or surgical condition (treated or untreated). * Any history of a clinically significant abnormality of the neurological system (including cognitive disorders or significant head injury) or any history of seizure (including febrile seizure).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording. | 9 weeks | Statistical paramaters of sleep measured by analysis of Polysomnography during night section of subject visit. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daytime cognitive function data on the morning following dosing, including tests of alertness, memory, attention and fine motor control (i.e. Romberg, VAS for sleepiness/alertness, DSST, and immediate and delayed word recall). | 9 weeks | Measurements of insomnia effects on daytime regular functions |
| Objective PSG measures of sleep continuity including: wake during sleep (WDS), wake after sleep (WAS), and number of awakenings during sleep. Objective PSG measures of sleep structure | 9 weeks | Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity. Data/graphs are collected and analysed post sleep. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. |
| Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording. | 9 weeks | Subject answers sleep quality questionnaires after night of sleep during the visit. Measured for each morning after each 4 study night visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. |
| Spectral analysis of EEG | 9 weeks | Collected as part of PSG. Graph spectra can be quantitatively analysed to assess electrical activity in the brain. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. |
| HVLT-R (verbal memory tests), TST, SOL, SQ, WAS and number of awakenings measured with the Post-Sleep Questionnaire score collected on specified mornings at home during the 3-day period following each 2-night PSG sessions. | 9 weeks | Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome. |
| Objective PSG measures of sleep structure: Non-REM sleep time, Slow-Wave Sleep (SWS) time (stage 3 and 4), Stage 2 non-REM sleep time; REM sleep time, REM activity, REM density. | 9 weeks | Real time Polysomnography technique using combination of EEG, ECG, EOG and EMG to collect data on physiological cleep activity. Data/graphs are collected and analysed post sleep. Measured for one night during each 4 study visits and twice at screening. All visits will take in total approximately 9 weeks from screening to follow-up. |
Countries
Germany
Outcome results
None listed