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

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

This study is currently recruiting participants.

Study NCT00705601. Last updated on November 17, 2008. Information provided by Pfizer

This Tabular View shows the required WHO registration data elements as marked by ^†

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

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 ]

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 ]

Condition ^†

Nonrestorative Sleep

Intervention ^†

Procedure: PSG

MEDLINE PMIDs

Links

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

Start Date ^†

July 2008

Completion Date

June 2009

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 persistant 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 admin 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

Gender

Both

Ages

18 Years to 64 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^†

United States, Canada

Administrative Information Fields

NCT ID ^†

NCT00705601

Organization ID

A9001380

Secondary IDs ^††

Study Sponsor ^†

Pfizer

Collaborators ^††

Investigators ^†

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

November 2008

First Received Date ^†

June 24, 2008

Last Updated Date

November 17, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.