Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study

Stopped early

Conditions studied: Nonrestorative Sleep

In brief

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 uncovering problems in instrument administration in subjects with nonrestorative sleep

Key facts

Study ID

NCT00705601

Run by

Pfizer

People needed

64

Starts

2008-08-01

Expected to finish

2009-01-01

Last updated by the study team

2019-03-04

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pfizer Investigational Site — Fountain Valley, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — Tustin, California, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Pembroke Pines, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Overland Park, Kansas, United States
• Pfizer Investigational Site — Crestview Hills, Kentucky, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Columbus, Ohio, United States
• Pfizer Investigational Site — Mississauga, Ontario, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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