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Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
This study has been terminated.
( See Detailed Description )
Study NCT00705601   Information provided by Pfizer
First Received: June 24, 2008   Last Updated: May 18, 2009   History of Changes

June 24, 2008
May 18, 2009
August 2008
January 2009   (final data collection date for primary outcome measure)
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00705601 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables. [ Time Frame: nightly ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables. [ Time Frame: nightly ] [ Designated as safety issue: No ]
  • Subjective measures include MAF (multidimentional 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 ] [ Designated as safety issue: No ]
 
Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep

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.

Phase II
Interventional
Screening, Non-Randomized, Open Label, Single Group Assignment
Nonrestorative Sleep
Procedure: PSG
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Terminated
64
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
18 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00705601
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
A9001380
Pfizer
 
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP