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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-01-31

Brief Summary

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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

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Detailed Description

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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 concerns.

Conditions

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Nonrestorative Sleep

Study Groups

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1

PSG

Intervention Type PROCEDURE

PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.

Interventions

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PSG

PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No