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

February 28, 2019 updated by: Pfizer

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Mississauga, Ontario, Canada, L5B 4M4
        • Pfizer Investigational Site
      • Toronto, Ontario, Canada, M6J 3S3
        • Pfizer Investigational Site
  • United States
    • California
      • 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
        • Pfizer Investigational Site
    • Florida
      • Miami, Florida, United States, 33143
        • Pfizer Investigational Site
      • Pembroke Pines, Florida, United States, 33026
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Pfizer Investigational Site
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Pfizer Investigational Site
    • Kentucky
      • Crestview Hills, Kentucky, United States, 41017
        • Pfizer Investigational Site
      • Louisville, Kentucky, United States, 40217
        • Pfizer Investigational Site
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
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
nightly

Secondary Outcome Measures

Outcome Measure
Time Frame
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
nightly
Secondary assessments to characterize the functional impact of insomnia including Nonrestorative Sleep include additional PSG (polysomnography) variables.
Time Frame: nightly
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
monthly

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

June 24, 2008

First Submitted That Met QC Criteria

June 25, 2008

First Posted (Estimate)

June 26, 2008

Study Record Updates

Last Update Posted (Actual)

March 4, 2019

Last Update Submitted That Met QC Criteria

February 28, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A9001380

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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