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| Descriptive Information Fields | |||||
| 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 |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Screening, Non-Randomized, Open Label, Single Group Assignment | ||||
| 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 ] |
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| Secondary Outcome Measure † | 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 ] |
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| Condition † | Nonrestorative Sleep | ||||
| Intervention † | Procedure: PSG | ||||
| MEDLINE PMIDs | |||||
| Links | To obtain contact information for a study center near you, click here. ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 65 | ||||
| Start Date † | July 2008 | ||||
| Completion Date | June 2009 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 64 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States, Canada | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00705601 | ||||
| Organization ID | A9001380 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Pfizer | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Pfizer | ||||
| Verification Date | November 2008 | ||||
| First Received Date † | June 24, 2008 | ||||
| Last Updated Date | November 17, 2008 | ||||