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

This study has been terminated.
(See Detailed Description)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00705601
First received: June 24, 2008
Last updated: February 1, 2011
Last verified: February 2011
  Purpose

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


Condition Intervention Phase
Nonrestorative Sleep
Procedure: PSG
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Refinement Of Patient Reported Outcomes Instruments In Subjects With Insomnia Characterized By Nonrestorative Sleep

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 64
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00705601

Locations
United States, California
Pfizer Investigational Site
Fountain Valley, California, United States, 92708
Pfizer Investigational Site
Pasadena, California, United States, 91106
Pfizer Investigational Site
San Diego, California, United States, 92121
Pfizer Investigational Site
Tustin, California, United States, 92780
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33143
Pfizer Investigational Site
Pembroke Pines, Florida, United States, 33026
United States, Georgia
Pfizer Investigational Site
Atlanta, Georgia, United States, 30342
United States, Kansas
Pfizer Investigational Site
Overland Park, Kansas, United States, 66212
United States, Kentucky
Pfizer Investigational Site
Crestview Hills, Kentucky, United States, 41017
Pfizer Investigational Site
Louisville, Kentucky, United States, 40217
United States, Ohio
Pfizer Investigational Site
Columbus, Ohio, United States, 43213
Canada, Ontario
Pfizer Investigational Site
Mississauga, Ontario, Canada, L5B 4M4
Pfizer Investigational Site
Toronto, Ontario, Canada, M6J 3S3
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00705601     History of Changes
Other Study ID Numbers: A9001380
Study First Received: June 24, 2008
Last Updated: February 1, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement

ClinicalTrials.gov processed this record on July 22, 2014