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
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.
Study Type
OBSERVATIONAL
Enrollment
64
PSG (polysomnography) for adaptation night, day 2 evening, and day 3 evening--used to identify suitable Nonrestorative Sleep candidates to participate in focus groups.
Pfizer Investigational Site
Fountain Valley, California, United States
Pfizer Investigational Site
Pasadena, California, United States
Pfizer Investigational Site
San Diego, California, United States
Once subjects identified, a series of focus group sessions will be held to identify concepts, themes and items relevant to Nonrestorative Sleep.
Time frame: 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.
Time frame: 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)].
Time frame: nightly
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.
Time frame: nightly
Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.
Time frame: 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.
Time frame: monthly
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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
...and 3 more locations