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Trial record 1 of 1 for:    NCT00705601
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Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study

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ClinicalTrials.gov Identifier: NCT00705601
Recruitment Status : Terminated (See Detailed Description)
First Posted : June 26, 2008
Last Update Posted : March 4, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 24, 2008
First Posted Date June 26, 2008
Last Update Posted Date March 4, 2019
Study Start Date August 2008
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 16, 2008)
  • 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 ]
Original Primary Outcome Measures
 (submitted: June 25, 2008)
  • 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 persistant sleep onset) and WASO (Wake after sleep onset) as determined by PSG (polysomnography)]. [ Time Frame: nightly ]
Change History
Current Secondary Outcome Measures
 (submitted: September 4, 2008)
  • 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 ]
Original Secondary Outcome Measures
 (submitted: June 25, 2008)
  • 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 ]
  • Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables. [ Time Frame: nightly ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Nonrestorative Sleep RSQ (Restorative Sleep Questionnaire) Development-- Methodology Study
Official Title Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep
Brief Summary 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 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
Study Design Not Provided
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition Nonrestorative Sleep
Intervention Procedure: 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.
Study Groups/Cohorts 1
Intervention: Procedure: PSG
Publications * Drake CL, Hays RD, Morlock R, Wang F, Shikiar R, Frank L, Downey R, Roth T. Development and evaluation of a measure to assess restorative sleep. J Clin Sleep Med. 2014 Jul 15;10(7):733-41, 741A-741E. doi: 10.5664/jcsm.3860.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: May 18, 2009)
64
Original Estimated Enrollment
 (submitted: June 25, 2008)
65
Actual Study Completion Date January 2009
Actual Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00705601
Other Study ID Numbers A9001380
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2019