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

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonrestorative Sleep
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- 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 reports LPS (latency to persistent sleep onset ) for (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 criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- 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

NCT00705601
Pfizer
Terminated
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study

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