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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
48
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Cottbus, Brandenburg, Germany
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, Germany
Total Sleep Time (TST), Latency to Persistent Sleep (LPS) and Wake time after sleep onset (WASO) derived from polysomongraphic (PSG) recording.
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.
Time frame: 9 weeks
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
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.
Time frame: 9 weeks
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.
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.
Time frame: 9 weeks
Spectral analysis of EEG
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.
Time frame: 9 weeks
Subjective Post-Sleep Questionnaire: TST, WASO, SOL, number of awakenings, and sleep quality (SQ) to be applied on each morning following PSG recording.
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GSK Investigational Site
Schwerin, Mecklenburg-Vorpommern, Germany
GSK Investigational Site
Dortmund, North Rhine-Westphalia, Germany
GSK Investigational Site
Münster, North Rhine-Westphalia, Germany
GSK Investigational Site
Dresden, Saxony, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
GSK Investigational Site
Berlin, State of Berlin, Germany
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.
Time frame: 9 weeks
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).
Measurements of insomnia effects on daytime regular functions
Time frame: 9 weeks
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.
Further questionnaires answered after each visit regarding sleep quality. Measured during night and day sections at each visit depending on the outcome.
Time frame: 9 weeks