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

NCT00705601

Last updated date
Study Location
Pfizer Investigational Site
Fountain Valley, California, 92708, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Nonrestorative Sleep
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-64 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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  8. San Francisco, California
  9. Tustin, California
  10. Wheat Ridge, Colorado
  11. North Haven, Connecticut
  12. Wallingford, Connecticut
  13. DeLand, Florida
  14. Miami, Florida
  15. Naples, Florida
  16. Orange City, Florida
  17. Orlando, Florida
  18. Pembroke Pines, Florida
  19. South Miami, Florida
  20. Atlanta, Georgia
  21. Atlanta, Georgia
  22. Gainesville, Georgia
  23. Chicago, Illinois
  24. Indianapolis, Indiana
  25. Overland Park, Kansas
  26. Crestview Hills, Kentucky
  27. Lexington, Kentucky
  28. Lexington, Kentucky
  29. Baton Rouge, Louisiana
  30. Chevy Chase, Maryland
  31. Brighton, Massachusetts
  32. N. Dartmouth, Massachusetts
  33. Chesterfield, Missouri
  34. St. Louis, Missouri
  35. Las Vegas, Nevada
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  37. West Seneca, New York
  38. Cary, North Carolina
  39. Raleigh, North Carolina
  40. Raleigh, North Carolina
  41. Salisbury, North Carolina
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  44. Cincinnati, Ohio
  45. Oklahoma, Oklahoma
  46. Clarks Summit, Pennsylvania
  47. Uniontown, Pennsylvania
  48. Warwick, Rhode Island
  49. West Warwick, Rhode Island
  50. Columbia, South Carolina
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  52. Dallas, Texas
  53. Irving, Texas
  54. Kelowna, British Columbia
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  56. Etobicoke, Ontario
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Advanced Information
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 CenterPfizer
PRS Account Pfizer
Verification Date February 2019