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

Study Overview
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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

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.

Official Title
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Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep

Conditions
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Nonrestorative Sleep

Intervention / Treatment
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* Procedure: PSG


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | Procedure: PSG<br>* PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep. |  | monthly | 
| To begin to refine the development of the RSQ measure in subjects with Nonrestorative Sleep by generating item content pertaining to morning refreshment and uncovering problems in instrument administration in subjects with nonrestorative sleep. |  | nightly | 
| Identification of subjects with insomnia characterized by Nonrestorative Sleep only [assessed via LPS (latency to persistent sleep onset) and WASO (Wake after sleep onset) as determined by PSG (polysomnography)]. |  | nightly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective measures include MAF (multidimensional assessment of fatigue), Sheehan Disability Scale, SF36v2, Endicott Work productivity scale (EWPS) Global impression of severity (CGIS) and the Profile of mood states. |  | nightly | 
| Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables. |  | nightly | 
| After phase IIa of this study, a questionaire to be designed - Participants to be debriefed, and interviewed to assess the content validity of the questionnaire. |  | monthly | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement