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Disturbed Sleep Model Study.

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 23, 2007
Last updated: May 31, 2012
Last verified: February 2011

February 23, 2007
May 31, 2012
January 2007
Not Provided
Total Sleep Time measured overnight across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
Total Sleep Time measured overnight across four treatment sessions (4 weeks)
Complete list of historical versions of study NCT00440323 on Archive Site
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks) [ Time Frame: 4 weeks ]
The effects on daytime cognitive function following dosing across four treatment sessions (4 weeks)
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Disturbed Sleep Model Study.
A Double-blind, Double-dummy, Randomised, Placebo-controlled,Four-way Crossover Study to Investigate the Effect of Single Oral Doses of SB-649868 and of Zolpidem in a Model of Noise Induced Situational Insomnia in Healthy Male Volunteers.
Subjects will be screened within 28 days. Each treatment session will consist of 2 PSG nights, study drug administration and noise model is conducted on second night.
Not Provided
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Sleep Initiation and Maintenance Disorders
  • Insomnia
  • Drug: SB-649868
  • Drug: Zolpidem
    Other Name: SB-649868
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Bettica P, Squassante L, Groeger JA, Gennery B, Winsky-Sommerer R, Dijk DJ. Differential effects of a dual orexin receptor antagonist (SB-649868) and zolpidem on sleep initiation and consolidation, SWS, REM sleep, and EEG power spectra in a model of situational insomnia. Neuropsychopharmacology. 2012 Apr;37(5):1224-33. doi: 10.1038/npp.2011.310. Epub 2012 Jan 11.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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Inclusion Criteria:

  • Body weight =50 kg and BMI within the range 18.5-29.9 kg/m2 inclusive
  • Healthy as judged by responsible physician.
  • No clinically significant abnormality identified on the medical or laboratory evaluation and 12-lead ECG;
  • The subject shows a normal sleep pattern on the basis of the evaluation of both PSG screening nights. Normal sleep will be defined as follows: LPS (Latency to persistence Sleep) <30min., SE (Sleep Efficiency) >85%, apnea/ hypopnea index < 10, periodic leg movements (PLM) with arousal index < 10. The apnea/hypopnea index is defined as "the number of apneas and hyponeas divided by the total sleep time (TST) expressed in hours". PLMI is defined as "the number of periodic leg movements associated with arousals or awakening divided by the total sleep time (TST) expressed in hour".

Exclusion Criteria:

  • A positive result for the pre-study urine drug/ alcohol breath screen.
  • Abuse of alcohol.
  • Subject complains of sleep disturbances and /or is receiving treatment for sleep disorders.
Sexes Eligible for Study: Male
18 Years to 55 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Study Director: GSK Clinical Trials GlaxoSmithKline
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP