Status:
COMPLETED
Disturbed Sleep Model Study.
Lead Sponsor:
GlaxoSmithKline
Conditions:
Sleep Initiation and Maintenance Disorders
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 5 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2007
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT00440323
Start Date
January 5 2007
End Date
July 3 2007
Last Update
August 17 2017
Active Locations (1)
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1
GSK Investigational Site
Guildford, Surrey, United Kingdom, GU2 7XP