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

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 II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Screening, Non-Randomized, Open Label, Single Group Assignment

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 ]

Estimated Enrollment:	65
Study Start Date:	July 2008
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 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.

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 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

Contacts and Locations

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

Contacts


Contact: Pfizer CT.gov Call Center	1-800-718-1021

Locations


United States, California
	Pfizer Investigational Site	Not yet recruiting
	Pasadena, California, United States, 91106
	Pfizer Investigational Site	Recruiting
	San Diego, California, United States, 92121
	Pfizer Investigational Site	Recruiting
	Fountain Valley, California, United States, 92708

United States, Florida
	Pfizer Investigational Site	Not yet recruiting
	Pembroke Pines, Florida, United States, 33026

United States, Kentucky
	Pfizer Investigational Site	Not yet recruiting
	Crestview Hills, Kentucky, United States, 41017
	Pfizer Investigational Site	Not yet recruiting
	Louisville, Kentucky, United States, 40217

United States, Ohio
	Pfizer Investigational Site	Not yet recruiting
	Columbus, Ohio, United States, 43213

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

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

Responsible Party:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A9001380
First Received:	June 24, 2008
Last Updated:	September 15, 2008
ClinicalTrials.gov Identifier:	NCT00705601
Health Authority:	United States: Food and Drug Administration

Keywords provided by Pfizer:

Nonrestorative Sleep, Restorative Sleep Questionnaire Refinement

ClinicalTrials.gov processed this record on September 23, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00705601