Status:
TERMINATED
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
Lead Sponsor:
Pfizer
Conditions:
Nonrestorative Sleep
Eligibility:
All Genders
18-64 years
Brief Summary
To begin to refine development of the RSQ (Restorative Sleep Questionnaire) measure in subjects with NRS (Nonrestorative Sleep) by generating item content pertaining to morning refreshment and uncover...
Detailed Description
Study was terminated on January 20, 2009 due to portfolio decision by Pfizer to discontinue further investigation of PD200390 for non-restorative sleep. The decision was not based on any safety concer...
Eligibility Criteria
Inclusion
- Subjects who self report nonrestorative sleep but no problems either getting to sleep or staying asleep
- Complaints of significant distress or impairment in social, occupational, or other important areas of functioning during daytime for at least 3 nights per week
- Self reports sWASO (Wake after sleep onset) for \<45 minutes for past 3 months, self reports LPS (latency to persistent sleep onset ) for \<20 minutes for past 3 months (then neither PSG (polysomnography) screening night showing WASO \>45min, or LPS \> 20 minutes)
- Customary bedtime betw. 9 pm and midnight and rise between 4 and 9 AM
Exclusion
- Psychiatric disease or disorder as determined by current administration of the MINI (Mini International Neuropsychiatric Interview)
- History or presence of any breathing-related sleep disorder, narcolepsy, or any other dyssomnias or any parasomnia, or restless legs syndrome MAP \> 0.5 at screening
- History or presence of any medical or neurological condition that could interfere with sleep (chronic pain, Restless leg, etc)
- Current use of meds wth known psychotropic effects or known or suspected effects on sleep
- Alcohol or substance abuse (unless in remission for at least a year
- Excessive caffeine use (or any use after 6 pm for at least 3 months
- Regular napping or any naps after 6 pm
- Excessive cigarette or cigar smoking over the last 3 months
- no participation in an investigational new drug study within 30 days of screening, and no previous participation in a study of PD200390
- No night or rotating shift work
Key Trial Info
Start Date :
August 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00705601
Start Date
August 1 2008
End Date
January 1 2009
Last Update
March 4 2019
Active Locations (13)
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1
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
2
Pfizer Investigational Site
Pasadena, California, United States, 91106
3
Pfizer Investigational Site
San Diego, California, United States, 92121
4
Pfizer Investigational Site
Tustin, California, United States, 92780